DRUGS & PHARMACEUTICALS
Any pharmaceutical product manufacturer requires a quality control which is one of the pre- requisite to regulatory compliances. Shagun Medi Testing is glad to inform that our lab is undertaking Analysis of product(s) covering Drug substance (API), Pharmaceuticals AID, Drug Formulations (Capsule, Cream, Ear Drops, Ointment, Gel, Oral Solutions, Oral Suspension, ORS, Injectables, Tablets, Vitamins etc.)
Data Integrity is the most essential part in our lab. The lab is well equipped to conduct all sorts of tests as per IP, BP, USP, and EP, NF or In-house tests methods. Our lab is occupied with latest art of sophisticated instruments up to benchmarks all are compliant to stringent requirement of 21 CFR parts 11 compliant, like:
- HPLC
- AAS
- GC
- Liquid Particle Counter
- HPTLC
- FTIR
- UV Spectroscopy
- GC-Headspace
- Disintegration Test Apparatus
- Dissolution Test Apparatus
- Melting Point Apparatus
- Friability Test Apparatus
- Karl Fisher
- Weighing Balance
- pH, Conductivity Meter
.
With the pro active support of all latest technology we provide the complete testing solutions for all parameters like:
- Assays and chemical tests
- UV/Vis
- IR
- Chromatographic tests
- HPLC
- GC
- Identification of active ingredients and impurities
- Physical and physico-chemical determinations
- pH
- Viscosity
- Melting point
- Loss on drying
- Limit tests
- Elemental impurities
- Ash
- Residual solvents
- Volatile organic compounds (VOC)
- Organic volatile impurities (OVI)
- Pharmaceutical technical procedures
- Disintegration
- Dissolution
- Element Impurities
- Micro Biology
- Stability Testing etc.
- Uniformity of Contents
- Bacterial Endotoxins
- Sterility
- Microbial Contamination etc.
We also have the facility to cover Pharmaceuticals Impurities Profiling (Organic & Inorganic) at PPT to percent Level according to IP, BP, USP (232/233)/ICH, IHS, EP, JP &WHO etc.
.In Pharmaceuticals Research and Development field we also provide support for Method Development and Validation and Stability testing of newly Synthesized Drug Formulations (Capsule, Cream, Ear Drops, Ointment, Gel, Oral Solutions, Oral Suspension, ORS, Injectables, Tablets, Vitamins) etc. as per ICH Guidelines.
COSMETIC & PERSONAL CARE PRODUCTS
Cosmetics are used almost universally on a regular basis. The safety in cosmetics and toiletries is of prime importance, as only safe products should be used by consumers. An EWG analysis of government and industry sources shows that at least 146 cosmetic ingredients may contain harmful impurities linked to cancer and other serious health hazards. Safety Assessment according the EC/1223/2009 Cosmetics Regulation, Annex I, part A and part B
Our services for Cosmetic & Personal Products (In Raw material and Finished products):
Quality Parameters:
Shagun Medi Testing Pvt Ltd. has fully operated chemical section to ensure the quality of cosmetics like pH, total fatty matter, identification of herbs and plant extract (By HPTLC), viscosity, consistency, fineness in skin creams and face packs, acid value and peroxide value in hair oils, foam height, active ingredients in shampoo, foreign dye in heena powder, menthol content in shaving cream by Gc-FID etc.
Other Critical and Essential Tests:
- Heavy metals
- Phthalates
- Preservative(Parabens, Sulphate)
- 1,4-Dioxane
- Bisphenol A
- Residual Formaldehyde
- GC- Profile
- Residual Solvents
- Aflatoxins
- Identification of Herbs
Ayurvedic and herbal products
(RAW AND FINISHED PRODUCTS)
Plant and their products are an essential source for human and other living organisms for the basic requirements related with nutrition, dietary needs, medicines, fuels etc. The demand of herbal drugs seems to be increased as the skepticism against the synthetic drugs and their growing side effects. However, with no harmful side effects plant preparation are often considered useful for the treatment of less serious diseases, for the supportive treatment of chronic diseases, for treatment over long periods of time, hence search and use of plant based drugs, dietary supplements and nutraceuticals have increased in recent years. Botanists, chemists, pharmacologists are combing the earth for natural phytochemicals and leads that they can utilized for treatment of chronic disorders.
Services for Ayurvedic and Herbal Products:
| Products | Testing Parameters |
|---|---|
| Raw drugs | As per API Foreign matter, Total ash, Acid insoluble ash, water soluble extractive, Alcohol soluble extractive, Thin layer chromatography |
| Tablets / pills | Description, Colour, Odour, Total ash, Acid insoluble ash, pH, Water soluble extractive, Alcohol soluble extractive, Loss on drying, Total solid content, Fat content, Total sugar, Friability, Hardness, Uniformity of weight, Disintegration time |
| Sharbat/ Syrup | Description, Colour, Odour, Viscosity, pH, Total solid, Total sugar, Reducing & non Reducing sugar, Specific gravity |
| Asva,Arishta,(Fermented liquid) | Description, Colour, Odour, pH, Specific gravity, Boiling point, RI, Optical rotation, Total acidity, Test for methanol, Reducing & non Reducing sugar |
| Ayurvedic Dusting powder | Description, Colour, Odour, Particle size (by Sieve method), Total ash, Acid insoluble ash, pH, Water soluble extractive, Alcohol soluble extractive, Loss on drying, Bulk density |
| Avaleha/semi solid | Description, Colour, Odour, Consistency, Total acidity, Total ash, Acid insoluble ash, pH, Water soluble extractive, Alcohol soluble extractive, Loss on drying, Total solid content, Fat content, Total sugar, Reducing & non Reducing sugar |
| Chewing candy | Description, Colour, Odour, Total ash, Acid insoluble ash, pH, Water soluble extractive, Alcohol soluble extractive, Loss on drying, Total solid content, Fat content, Total sugar, Reducing & non Reducing sugar, Salt content, Friability, Hardness, Uniformity of weight, Disintegration time |
| Oils & Ghee | Description, Colour, Odour, pH, Specific gravity, Boiling point, Essential oil, RI, Optical rotation, Viscosity. Rancidity, Iodine value, Saponification value, Unsaponifiable matter, Acid value, Peroxide value, Free Fatty acid, Fatty matter, Mineral oil test |
| Churna (fine & Coarse powder | Description, Colour, Odour, Particle size (by Sieve method), Total ash, Acid insoluble ash, pH, Water soluble extractive, Alcohol soluble extractive, Loss on drying, Bulk density, Alkaloids, Tannins, Phenols, Flavonoids |
| Lepa/ Wax/ Cream | Description, Colour, Odour, Viscosity, Rancidity, Total acidity, Uniformity of content, pH, Thermal, Stability, Fat content, LOD, Spreadibility |
| EYE drops | Description, Colour, Odour, pH, Clarity test |
| Plant extract | Description, Colour, Odour, Volatile oil content, Total ash, Acid insoluble ash, pH, Water soluble extractive, Alcohol soluble extractive, Loss on drying, Bulk density, Residual solvent, Alkaloids, Tannins, Phenols, Flavonoids, Saponins |
| Bhasam / Pishti | Description, Colour, Odour, Total ash, Acid insoluble ash, pH, Water soluble extractive, Alcohol soluble extractive, Loss on drying, Particle size (by Sieve method), Sulphated ash, Assay for element (2 major elements), Nishchandrica, Rekhapurntava, Varitara, Nirthoom, Niswadu,, Apurnar Bhav |
| Granules | Description, Colour, Odour, Bulk & Tap density, Compressibilty, Total ash, Total sugar, Reducing & non Reducing sugar, Total ash, Acid insoluble ash, pH, Water soluble extractive, Alcohol soluble extractive |
| Raw plant material | Description, Colour, Odour, Volatile oil content, Foreign matter, Total ash, Acid insoluble ash, pH, Water soluble extractive, Alcohol soluble extractive, Loss on drying. |
Nutraceuticals and Functional Food
Nutraceutical or ‘bioceutical’ is a pharmaceutical alternative which claims physiological benefits. “Nutraceuticals” are largely unregulated, as they exist in the same category as dietary supplements and food additives by the FDA, under the authority of the Drug and Cosmetic Act.
Functional foods are fortified or enriched during processing and then marketed as providing some benefit to consumers. Sometimes, additional complementary nutrients are added, such as vitamin D to milk.
Functional foods are “ordinary food that has components or ingredients added to give it a specific medical or physiological benefit, other than a purely nutritional effect.” All functional foods must meet three established requirements: foods should be present in their naturally occurring form, rather than a capsule, tablet, or powder; consumed in the diet as often as daily; and should regulate a biological process in hopes of preventing or controlling disease.
Services for Nutraceuticals and Functional Food:
Nutritionals & Contaminants
|
Active components of Nutraceuticals
|
Water Testing:
Shagun Medi Testing Pvt Ltd offers a comprehensive water testing service for the packaged drinking water manufacturers and food and beverages processing companies. With state of-the-art facilities and the latest analytical methodologies, SMPTL offers a complete analysis which includes Pesticides residue, Heavy metals, Microbiological detection, Physical tests, Sensory tests, Chemical tests, PAHs, PCBs, Other miscellaneous tests. Our testing services are specifically made to meet the water testing requirements.
Pharmaceutical grade water: We also offers complete testing of Pharmaceutical grade waters like: Purified water, water for injection, etc as per IP,BP,USP,EP,JP and In house specifications;
Parameters offered:
| Colour, Hazen | Silver | Mercury |
| Odour | Selenium | Cadmium |
| Taste | Molybdenum | Lead |
| Turbidity | Boron | Nickel |
| Dissolved solids | Nitrate | Cyanide |
| pH value | Sulphate | Polychlorinated biphenyls |
| Total hardness | Sulphide | Trihalomethanes |
| Iron | Fluoride | Bromoform |
| Aluminium | Chlorides | Dibromochloro methane |
| Copper | Ammonia | Bromodichloro methane |
| Manganese | Chlorine | Chloroform |
| Zinc | Mineral Oil | Polyaromatic Hydrocarbons |
| Magnesium | Anionic detergents | |
| Barium | Total Chromium | |
| Calcium | Total Arsenic |
Radioactive Materials
Alpha emitters
Beta emitters
Microbial testing
E coli
Salmonella
Total Coliform
Pesticide residues
120+ different pesticide residue analysis available
Biological Testing:
Microbiological quality is critical in Pharma, Cosmetic, Food and Feed product safety assessment. Microbial testing is essential to identify borne pathogens and spoilage organisms. This testing can ensure continued safety of products along the supply chain. Monitoring of functional microbes which may be entered during production or in the final product is equally important.
Our microbial analysis will help clients to assess the safety and efficacy of ingredients, semi manufactured, final products and the entire processing steps. We have state of the art testing laboratory with most advanced technologies and experts developing up-to-date standards for microbial testing for diverse Pharma and Food samples.
Current microbiological testing Services:
Pathogens:
- Salmonella species
- Listeria monocyogenes and species
- Escherichia coli, O157:H7, O157, and STECs
- Staphylococcus aureus
- Campylobacter species
- Bacillus cereus
- Shigella species
- Clostridium perfringens
- Cronobacter sakazakii
- Pseudomonas aeroginosa
Indicators & Spoilage Organisms:
- Aerobic Plate Count
- Yeast & Mold
- Coliforms
- Enterobacteriaceae
- Lactic Acid Bacteria
- Alicyclobacillus
- Heterofermentative Lactic Acid Bacteria
- Spore-forming Mesophilic Aerobic Bacteria
- Spore-forming Mesophilic Anaerobic Bacteria
- Spore-forming Thermophilic Aerobic Bacteria
- Osmophilic Yeast & Mold
- Anaerobic Plate Count
- Psychotropic Plate Count