Microbial Limit Test Research Articles

Efficacy of sucralfate ointment in the prevention of acute proctitis in cancer patients: A randomized controlled clinical trial.

Background:Acute radiation proctitis (ARP) is a usual adverse effect in patients undergoing pelvic radiotherapy. The symptoms include diarrhea, rectal blood or mucus discharge, fecal urgency and tenesmus with pain. Sucralfate, an aluminum-based salt of sucrose octasulfate, is a cytoprotective agent that forms a coating barrier at injured sites by adhering to mucoproteins. It has been used in topical management of a wide variety of local lesion. This study was designed to evaluate the preventive effect of rectal sucralfate on acute radiotherapy induced proctitis.Methods:Seven percent sucralfate ointment was prepared for topical use. Drug quantification, chemical stability and microbial limit tests were performed carefully. In this randomized double blind placebo controlled trial, fifty-seven patients with pelvic malignancies undergoing radiotherapy were allocated to receive either 1 g of sucralfate or 1 g of placebo, given as a twice daily ointment, one day before and during radiotherapy for six weeks. The eligible patients were evaluated based on RTOG acute toxicity criteria and the following ARP symptoms weekly: rectal hemorrhage, diarrhea, rectal pain, and fecal urgency. The influence of symptoms on lifestyle was also recorded weekly.Results:Acute proctitis was significantly less prevalent in patients in the sucralfate group. The incidence of rectal bleeding (P=0.003), diarrhea (P=0.002), rectal pain (P=<0.001) and fecal urgency (P=0.002) was significantly less common in the sucralfate group. No statistical significant difference was observed for radiotherapy induced cystitis in the placebo and sucralfate groups (P=0.27).Conclusion:This study suggests that sucralfate7% ointment reduces the incidence of symptoms associated with acute radiation proctitis.

Methodological verification of microbial limit test for compound miconazole nitrate ointment

Methodological verification of microbial limit test for compound miconazole nitrate ointment

Effects of gamma radiation treatment on three different medicinal plants: Microbial limit test, total phenolic content, in vitro cytotoxicity effect and antioxidant assay

The aim of this study is to evaluate the effects of gamma radiation treatment on three medicinal plants, namely Euodia malayana, Gnetum gnemon and Khaya senegalensis at two different forms; methanol leaf extracts and dried leaves respectively. The microbial limit test (MLT) studies indicated the suitable dosage of minimum and maximum gamma irradiation for leaf extracts as well as dried leaves of all the tested medicinal plants. Quantitative analysis of total phenolic content (TPC) analysis is based on calorimetric measurements determined using the Folin-Ciocalteu reagent with gallic acid (GA) used as the reference. In vitro cytotoxicity assay by using fibroblast (L929) cell lines was performed on each plant to determine the toxicity effect which sodium dodecyl sulfate (SDS) as the positive control. DPPH (2,2-diphenyl-1-picryl-hydrazyl) assay was conducted by using vitamin C and GA as the positive controls to determine the antioxidant property of each plant. The MLT analysis indicated that the suitable dosage gamma irradiation for leaf extracts was 6-12kGy and dried leaves were 9-13kGy. The amount of GA concentration in each plant increased significantly from 30-51mg GAE g-1 before treatment to 57-103mg GAE g-1 after treatment with gamma radiation. This showed no significant effect of in vitro cytotoxicity activity before and after treatment with gamma irradiation in this study. Effective concentration (EC50) values of Khaya senegalensis plant reduced significantly (P≤0.005) from 44.510μg/ml before treatment to 24.691μg/ml after treatment with gamma radiation, which indicate an increase of free radical scavenging activity.

Preformulation, stress stability studies and HPLC-UV method development and validation for 95 % ethanol extract of Moringa oleifera Lam. Leaves

Introduction: There is a continuous expansion in number of botanical medicinal products and increase in consumers who often use it. One of such natural source products with versatile traditional uses as treatment for variety of diseases is Moringa oleifera Lam. Objectives: After the pharmacological activity of a new drug candidate is approved, the subsequent development of this product requires substantial information about its physical and chemical properties before designing its dosage form. Methods: Organoleptic properties, physicochemical characteristics, solubility profile, swelling index, partition coefficient, analyses of thermal behaviour, stress stability, heavy metals and microbial limit tests were performed in preformulation studies of 95 % ethanol extract of M. oleifera leaves. Results: The results of preformulation studies illustrated several characteristic properties that should be consider during formulation of Moringa extract. In addition to that, a HPLC-UV method for simultaneous detection and quantification of three reference markers was developed and validated. Conclusion: The 95 % ethanol extract of Moringa leaf is relevant to the development of phytomedicines, dietary supplements or cosmetics. To the best of our knowledge, the present study is the first preformulation study which aimed to determine the physicochemical properties of 95 % ethanol extract of Moringa oleifera leaf.

Effect of Beneng Taro Starch (Xanthosoma undipes K. Koch) Concentration as Disintegrant on Active Ingredient and Microbial Limit Test of Paracetamol 500 mg Tablets

Sediaan tablet terdiri atas zat aktif dan eksipien. Eksipien atau zat tambahan pada formulasi tablet dapat berupa zat pengisi, zat pengikat dan adhesif, disintegran (penghancur), lubrikan, glidan, antiadheren, adsorben, zat penyedap, dan zat pewarna. Eksipien merupakan zat inert secara fisik, kimia, dan farmakologi yang ditambahkan ke dalam formulasi sediaan tablet untuk membantunya memenuhi persyaratan proses teknologi, persyaratan spesifikasi teknis, fisik, penampilan, persyaratan mutu resmi (farmakope). Eksipien penting untuk sediaan tablet adalah bahan penghancur. Bahan penghancur mempengaruhi pelepasan zat aktif obat dari sediaan untuk kemudian dapat memberikan efek terapi yang diinginkan. Salah satu bahan penghancur adalah amilum atau pati. Tanaman yang berpotensi memiliki kadar pati yang tinggi adalah talas beneng. Umbi Xanthosoma undipes K. Koch sendiri memiliki kadar pati sebesar 15.21%. Penelitian ini bertujuan untuk mengetahui pengaruh konsentrasi pati talas beneng terhadap kadar dan batas mikroba tablet parasetamol 500 mg. Pembuatan tablet dilakukan dengan kempa langsung dengan variasi konsentrasi pati talas beneng sebagai penghancur yaitu 0% (FI), 5% (FII), 10% (FIII) dan 15% (IV). Hasil penetapan kadar menunjukkan bahwa semua formulasi memenuhi persyaratan kadar Farmakope Indonesia yaitu FI = 100,27%; FII = 99,95%; FIII = 100,06%; dan FIV 99,85%. Uji batas mikroba menunjukkan bahwa Angka Lempeng Total FI = 20 cfu/g; FII = 35 cfu/g; FIII = 10 cfu/g; FIV = 50 cfu/g. Angka Kapang Kamir yaitu FI = 110 cfu/g; FII = 100 cfu/g; FIII = 50 cfu/g; FIV = 150 cfu/g. Uji bakteri patogen menunjukkan bahwa semua formula tidak tercemar bakteri patogen. Kata kunci: tablet, Xanthosoma undipes K.Koch, parasetamol, penetapan kadar, mikroba

DEVELOPMENT OF COSMETIC CREAM CONTAINING A PHARMACEUTICAL COCRYSTAL OF SALICYLIC AND PHENYLALANINE

Objective: The objective of this present work was to develop the chemical peeling cream containing the synthesized active ingredient pharmaceutical cocrystal of salicylic acid and phenylalanine.&#x0D; Methods: The salicylic acid and phenylalanine cocrystal (H2Sal·Phe) was synthesized by the solvent evaporation method and characterized by various techniques such as single-crystal X-ray diffraction and Fourier transform infrared spectroscopy. The five formulas of cocrystal cream were prepared. All formulas were then examined and observed for appearance, spreadability, viscosity, pH, homogeneity, SPF test, microbial limit test and stability test.&#x0D; Results: The (H2Sal·Phe) consists of no zwitterion phenylalanine for the first time. X-ray crystal structure of cocrystal consists of double H2Sal and Phe molecules with stabilized by inter-, intra-molecular and π-π interactions. By using this cocrystal as an active ingredient for cosmetic development, the chemical peeling cream was produced along with the pharmaceutical examinations. The (H2Sal·Phe) formulations were prepared 0-1% and excipients included of jojoba oil, isopropyl myristate, castor oil, glyceryl monostearate cetostearyl alcohol, cyclomethicone (and) dimethicone crosspolymer, vitamin E, white bee's wax, glycerin, PEG 400, xanthan gum, Span 80 and Tween 60. We finally found that the F4 (1% H2Sal·Phe) was the best formulation with suitable physical properties of cream and chemical stable after storage. The results of cell viability show H2Sal·Phe is non-toxic with cell.&#x0D; Conclusion: The chemical peeling cream containing (H2Sal·Phe) has shown the promising results which are both safe and efficacious peeling agent. Cocrystal (H2Sal·Phe) cream can be used as an alternative choice in whitening skin.

Pharmacognostical, Physicochemical Standardization and In vitro Antioxidant Activity of Punica granatum Linn fruit

Introduction: Punica granatum Linn. fruit (Family: Punicacea), known as Pomegranate is ethno-medicinally prescribed in various part of world for treatment of different diseases it is used as antioxidant, hepatoprotective, anticancer and antiparasitic agent. Method: The present study was thus undertaken to find out the necessary pharmacognostical standards for evaluating the fruit of P. granatum. Different assessment such as macroscopical characters, microscopical studies, physicochemical evaluations (loss on drying, moisture content by Karl Fischer titration, ash values, extractive values) and TLC/HPTLC finger print profiling were performed and the relevant quantitative and qualitative parameters were reported. Invitro antioxidant activity is also performed by HPLC-DPPH method. Results: Fruit of P. granatum are Reddish brown in color, Globular and Oval, smooth, 5.0 o 12.0 cm in diameter. Powdered fruit confirmed the presence of Stone cell, Endospermic cell, Group of stone cells, Nonlignified fiber, Starch grain and Lignified fibers and vessels. TLC of the extracts was also carried out in the current study. Physicochemical standards quantified include loss on drying (36.62 ± 4.17 %), moisture content (32.15 ± 3.64 %) total ash (8.58% ± 1.06 %), water soluble ash (7.15 ± 0.97 %), acid insoluble ash (0.45 ± 0.03 %). Safety profile of plant part was recognized by quantify microbial limit test, pesticide residue and heavy metals (Cd, As, Hg and Pb) evaluation. Here is no visible microbial growths were seen in sample. Pesticide residue and heavy metals were observed to be present within the acceptable limits. Conclusion: Scientific investigations do not yet exist to identify the exact plant part and to determine its quality and purity. These studies provided referential information for accurate identification and standardization of this herbal material. These analyses will also be useful to distinguish P. granatum from the closely associated to other species of Punica.

Verification of the Test for the Detection of Specified Micro-organisms in the 17th Edition of the Japanese Pharmacopoeia &lt;5.02&gt; Microbial Limit Test for Crude Drugs and Preparations Containing Crude Drugs as the Main Ingredient

Verification of the Test for the Detection of Specified Micro-organisms in the 17th Edition of the Japanese Pharmacopoeia &lt;<i>5.02</i>&gt; Microbial Limit Test for Crude Drugs and Preparations Containing Crude Drugs as the Main Ingredient

Anti-Halitosis Tooth Paste: From Persian Manuscripts toward Clinic

Background and objectives: Halitosis as a common dentistry ailment which has a prevalence of around 50% of the adult population. There are many dental formulations in traditional Persian pharmacy called “Gharagher”, “Mazmazeh”, “Sonoun”, etc for treatment of halitosis. In the present study, we have tried to describe the step by step modernization of traditional herbal advices for treatment of halitosis. Methods: Traditional Persian manuscripts were reviewed and dome herbs were selected for formulation of toothpaste. Qualitative and quantitative controls were performed on raw materials and toothpaste was formulated using the selected herbs. Pharmaceutical control tests including squeeze, centrifuge, conductivity, particle size, spreading, temperature related stability, and microbial limit tests were performed on the toothpastes. Results: A total of 31 medicinal plants from 24 plant families and 12 anti-halitosis “Sonoun”s possessing anti-halitosis related properties were found. Syzygium aromaticum, Pistacia atlantica var. mutica, and Punica granatum var. pleniflora were selected for the formulation. Results of quality contril assays were in the accepted range of pharmacopeias. GC-MS analysis showed 15 and 16 components in P. atlantica and S. aromaticum oils, respectively. GC-FID results showed 85.15% α-pinene in P. atlantica and 5.28% eugenol in S. aromaticum. ATR-IR spectrum was used for control of P. granatum flowers. The organoleptic properties, phase separation, particle size and microbial tests of formulations showed an accepted shelf life for performing clinical trials. The results proved a good texture property as well as desirable abrasive properties of the toothpaste. Post production quality control tests indicated the proper feature of final product after packaging. Conclusion: Such model would be a straight forward rout from traditional medical manuscripts toward clinic.

Study on the applicability of microbial limit tests for six kinds of traditional Chinese patent medicines

Study on the applicability of microbial limit tests for six kinds of traditional Chinese patent medicines

Quality Assessment of Some Essential Children's Medicines Sold in Licensed Outlets in Ashanti Region, Ghana.

The quality of 68 samples of 15 different essential children's medicines sold in licensed medicine outlets in the Ashanti Region, Ghana, was evaluated. Thirty-two (47.1%) of the medicines were imported, mainly from India (65.6%) and the United Kingdom (28.1%), while 36 (52.9%) were locally manufactured. The quality of the medicines was assessed using content of active pharmaceutical ingredient (API), pH, and microbial limit tests, and the results were compared with pharmacopoeial standards. Twenty-six (38.2%) of the samples studied passed the official content of API test while 42 (61.8%) failed. Forty-nine (72.1%) of the samples were compliant with official specifications for pH while 19 (27.9%) were noncompliant. Sixty-six (97.1%) samples passed the microbial load and content test while 2 (2.9%) failed. Eighteen (26.5%) samples passed all the three quality evaluation tests, while one (1.5%) sample (CFX1) failed all the tests. All the amoxicillin suspensions tested passed the three evaluation tests. All the ciprofloxacin, cotrimoxazole, flucloxacillin, artemether-lumefantrine, multivitamin, and folic acid samples failed the content of API test and are substandard. The overall API failure rate for imported products (59.4%) was comparable to locally manufactured (63.9%) samples. The results highlight the poor quality of the children's medicines studied and underscore the need for regular pharmacovigilance and surveillance systems to fight this menace.

Reformulation of Traditional Chamomile Oil: Quality Controls and Fingerprint Presentation Based on Cluster Analysis of Attenuated Total Reflectance-Infrared Spectral Data.

Herbal oils have been widely used in Iran as medicinal compounds dating back to thousands of years in Iran. Chamomile oil is widely used as an example of traditional oil. We remade chamomile oils and tried to modify it with current knowledge and facilities. Six types of oil (traditional and modified) were prepared. Microbial limit tests and physicochemical tests were performed on them. Also, principal component analysis, hierarchical cluster analysis, and partial least squares discriminant analysis were done on the spectral data of attenuated total reflectance–infrared in order to obtain insight based on classification pattern of the samples. The results show that we can use modified versions of the chamomile oils (modified Clevenger-type apparatus method and microwave method) with the same content of traditional ones and with less microbial contaminations and better physicochemical properties.

PVA-PEG physically cross-linked hydrogel film as a wound dressing: experimental design and optimization

The development of hydrogel films as wound healing dressings is of a great interest owing to their biological tissue-like nature. Polyvinyl alcohol/polyethylene glycol (PVA/PEG) hydrogels loaded with asiaticoside, a standardized rich fraction of Centella asiatica, were successfully developed using the freeze–thaw method. Response surface methodology with Box–Behnken experimental design was employed to optimize the hydrogels. The hydrogels were characterized and optimized by gel fraction, swelling behavior, water vapor transmission rate and mechanical strength. The formulation with 8% PVA, 5% PEG 400 and five consecutive freeze–thaw cycles was selected as the optimized formulation and was further characterized by its drug release, rheological study, morphology, cytotoxicity and microbial studies. The optimized formulation showed more than 90% drug release at 12 hours. The rheological properties exhibited that the formulation has viscoelastic behavior and remains stable upon storage. Cell culture studies confirmed the biocompatible nature of the optimized hydrogel formulation. In the microbial limit tests, the optimized hydrogel showed no microbial growth. The developed optimized PVA/PEG hydrogel using freeze–thaw method was swellable, elastic, safe, and it can be considered as a promising new wound dressing formulation.

Formulation and evaluation of antioxidant cream containing methanolic extract of Piper betel leaves

The Reactive oxygen species (ROS) accelerates the intracellular and extracellular oxidative stress and considered as a cause that leads to skin aging, which is characterized by wrinkles and atypical pigmentation. The antioxidant activity of the Piper Betel leaves were researched previously by many researchers, but there is no information with formulation of an antioxidant cream. Take this as consideration, the present study is focused to formulate and evaluate the antioxidant cream comprising the methanolic leaves extract of Piper betel. The in-vitro free radical scavenging activity was studied by using stable 2,2 -Diphenyl-1-picrylhydrazyl (DPPH). The leaves extract showed commanding high radical scavenging properties, the half maximal inhibitory concentrate (IC50) result revealed that leaves of piper betel shows good antioxidant properties with 56.88µg/ml. The formulation comprises with 2% of extract and was formulated using fusion method. The formulation was subjected to standard evaluation process on the following parameters like pH, homogenecity, spreadability, non-volatile matter at 105°C, rheological study, microbial limit test and physical stability of cream.The evaluation of the formulated cream showed good results and can be good potential for cosmetic product development.Further study has to be conducted on masking the colour and to enhance the pleasant odour of the formulated cream.

Physicochemical Properties, Heavy Metal Content and Microbial Limit Test of Bedak sejuk

Background/Objectives: At present, no study has been conducted to evaluate the safety of bedak sejuk as a cosmetic product. Hence in this study, the safety evaluation of bedak sejuk which is used daily by Malaysians was investigated. Methods: Five assessment tests were studied on physicochemical properties of bedak sejuk which includes determination of pH, moisture and volatile matter, matter insoluble in water, test for solubility of colours and fineness. Heavy metal content (lead) and microbial population limit tests were also executed. Findings: Results showed that bedak sejuk complies with the cosmetic powder standard, in which the pH of bedak sejuk was at 6.0±0.3, the moisture and volatile matter was at 1.1±0.6%, matter insoluble in boiling water was 68±0.7 mg/mass, the results of colour solubility was rated colourless and presented in a normal particle distribution. For the heavy metal content, less than 3.5±0.5 parts per million of lead in the sample was observed while for the microbial population limit test, was valued at 340 CFU/mL. Application: From these results, bedak sejuk has the potential to be be marketed as loose powder in canisters or molded or compressed into cakes and inserted into mirrored compact cases, typically with an applicator, usually a pad, a puff or other implement.

PHYSICO CHEMICAL EVALUATION OF AVIPATTIKARA CHURNA AND ITS DEVELOPED FORM OF SYRUP

Development and modification of Ayurvedic classical formulations into widely acceptable dosage forms is an important area to be focused in the present era. The designing of liquid dosage form has generally been emphasized on the basis of ease of administration to those individuals who have difficulty in swallowing solid dosage forms, specially in pediatric and geriatric group. Churna (powders) are the preferentially administered Ayurvedic formulations by oral route. Most of these powders are hygroscopic, bitter to taste and should be administered with suitable vehicle. Avipattikara Churna is one of the unique formulation widely practiced in the management of common ailments like Amlapitta (hyperacidity), Vibandha (constipation), Agnimandya (loss of appetite), Arsha (hemorrhoids). Modification of the classical Churna (solid dosage form) into a more acceptable and convenient syrup (liquid dosage form) with modern pharmaceutical methods and its physico-chemical analysis is the main aim of the study. In the present study Avipattikara syrup was developed with 66.7 % w/V of Khandasharkara (sugar candy powder) without any pharmaceutical additives. Physicochemical analysis, microbial limit test, and physical quality tests for Avipattikara Churna and syrup were carried out respectively. Results suggest that, the developed syrup had a quality of ideal syrup.

Validation of Method in Microbial Limit Tests for Two Types of Health Foods

In order to discuss that whether the methods of total aerobic microbial count and absence bacterial test were appropriate in microbial limit tests for health foods hygiene. As the requirement of microorganism limits test and validation on the Chinese Pharmacopoeia 2010, the microbial examination method of two kinds of health foods has been validated. It is found that vitamin B was antibacterial for <em>Bacillus subtilis</em> and <em>Aspergillus niger</em>. The results indicated the method in foods microbial limit test GB/T4789-2010 were not suitable for the microbial limit tests of health foods. It is suggested that setting more reasonable method by validation as well as referring to the Chinese Pharmacopoeia 2010.

Quality and Safety Evaluation of Commercial Mangosteen (Garcinia mangostana Linn.) Capsule

&lt;p&gt;Many herbal food supplements today are being sold in market and most popular among them is the commercial mangosteen (Garcinia mangostana Linn.) capsule. With the present scenario, this study focused on ensuring the quality of commercial mangosteen (Garcinia mangostana Linn.) capsule being sold in the market for consumer’s safety. Based on results of experimentations, the sample of commercial mangosteen capsule passed all the tests conducted. The disintegration time using water and simulated gastric fluid as a solvent was within the 30 minutes specification set by 22nd edition of USP XXII/ NF XVII, which was at 21.88 minutes and 10.83 minutes, respectively. Result also revealed that commercial mangosteen capsule was more soluble in simulated gastric fluid when compared to water since, in the first test, all the capsule disintegrated completely within 30 minutes at a lower mean disintegration time and the residue left after the experimentation was lesser. For microbial limit tests, the Aerobic Plate Count (CFU/g) was 540 (normal limit - 104), Yeast (CFU/g) at 135 (normal limit -103), and Molds (CFU/g) at 10 (normal limit- 103). Lastly, for heavy metal load, Cadmium (ug/g) has &amp;lt;0.05 (normal limit - 0.3) and Lead (ug/g) has 2.73 (normal limit – 10). All results conformed to FDA Guidelines. Therefore, commercial mangosteen capsule has met the minimum quality control standard and is safe for human consumption based on the 22nd edition of USP XXII/NF XVII specifications and FDA Guidelines.&lt;/p&gt;

Beyond-use date of extemporaneous morphine hydrochloride oral solution

Hospital pharmacists prepare morphine oral solution extemporaneously in Taiwan because of the unavailability of commercial products. According to the United States Pharmacopeia <795>, extemporaneous oral solution has an expiration of 14 days if there is no stability test data. However, outpatients usually need 4-week medications. The purpose of this study was to determine the beyond-use date of extemporaneous morphine hydrochloride (HCl) oral solution. Extemporaneous 0.1% morphine HCl oral solutions were prepared in an International Organization for Standardization (ISO) Class 8 compounding room, and bottled in 500-mL high-density polyethylene (HDPE) bottles with polypropylene caps. Twelve bottles were divided into 2 groups (sealed or opened daily) and stored under refrigeration or at room temperature to determine the chemical and microbial stabilities. Stability tests of the “sealed” group were performed after 4 weeks, while for the group in which the bottles were shaken and opened twice daily, stability tests were performed weekly. Chemical stability was determined by high performance liquid chromatography and pH, and microbial stability was determined by microbial limit tests according to pharmacopeias. In both groups, all the morphine HCl oral solutions retained more than 90% of the original concentration after 4 weeks, irrespective of whether they were stored at room temperature or in the refrigerator. The pH values were maintained at around 5 during the 4-week study period. All the refrigerated solutions passed the microbial limit tests within 4 weeks, regardless of whether they were sealed or opened twice daily. All the solutions stored at room temperature retained their microbial stability in the 1st week. However, mold and yeast counts exceeded the limits during the 2nd week in the “opened daily” group. Extemporaneous 0.1% morphine HCl oral solutions prepared in an ISO Class 8 clean room have a beyond-use date of 4 weeks in HDPE bottles when refrigerated. The beyond-use date decreased to 1 week when stored at room temperature. Extrapolation of this result may be limited by different compounding environments, containers or formulations.

Physicochemical Analysis of Dashanga Agada – An Ayurvedic Formulation

Background: Standardization of herbal formulation is essential to assess the quality of drugs. This article reports on standardization of Dashanga Agada, an Ayurvedic formulation indicated in various poisonous and non-poisonous conditions by Ayurvedic as well as traditional Keralian Visha Vaidyas. Aims: Physicochemical standardization of Dashanga Agada. Methodology: Dashanga Agada was prepared as per classics in Gullika (Tablet) form. In-house preparation has been standardized on the basis of organoleptic characters, physical characteristics, Physico-chemical properties, High performance thin layer chromatography (HPTLC) and Thin layer chromatography (TLC) methods. Results: pH of Dashanga Agada at 5% aqueous solution was 4.58%w/v, Loss on drying at 110C 10.57% w/w, Total Ash 8% w/w, Acid Insoluble Ash 2.45% w/w, Water Soluble Ash 23.85% w/w, Alcohol Soluble Extractive 15.87% w/w, Methanol Soluble Extractive 23.66% w/w. Fluorescence analysis results indicated no fluorescent material in formulation. Microbial limit test (MLT) showed there was no growth of organisms after 24hrs of incubation as per IP. Thin Layer chromatographic analysis (TLC) showed 10 and 11 picks at 254nm and 366nm respectively. Conclusion: The set parameters can be used as reference standards for the quality control.