PHARMACEUTICALS TESTING DIVISION

Today, drug and pharmaceutical manufactures face ever-increasing pressures to keep pipelines full, control research and development costs, deliver more drugs to the market and build and increase shareholder value. To succeed in this environment, you need a partner with the knowledge, infrastructure and resources to assist you to propel innovations and accelerate the drug development and quality control processes.

Whether you may require a single test on your product or an entire quality control solution, we are ready to put our minds at work for you to assist you to deliver your product at an unsurpassed velocity into the market.

Geo Chem Laboratories' services offer a full spectrum of resources to assist the drug and pharmaceutical development and the quality control processes. Whether it be bulk drugs, intermediates or finished products, our testing and product certification facility located in Mumbai will cater to your needs.

The pharmaceutical testing division is approved by FDA, Maharashtra for all pharmaceutical products and Herbal medicines. We are also approved by Customs - Export & Import

Our state of-the-art FDA approved laboratory in Mumbai setup ably supports in the testing and analysis of wide range of products as per National and International standards and specific customer requirements.

Our services includes Inspection, Sampling, Analysis and Stability studies of Drugs, Drug Intermediates and Pharmaceutical Formulations.

Geo chem. Laboratories inspects and samples pharmaceuticals, intermediates, formulations, bulk drugs etc. in bulk bagged or drummed packing. These are done on behalf of manufactures, traders, exporters, buyers agencies, authorities, insurance companies, ship owners.

Inspections and sampling are undertaken at the request of clients and samples drawn can be tested and certified in accordance to the contractual specifications agreed between buyers, sellers and manufacturers.

Geo chem analytical services is a key to the testing of all forms of pharmaceutical products.

Analysis done as per Pharmacopeias such as IP, BP, USP, EP and other International Pharmacopeias.

Analysis and product certification of

• Pharmaceutical Bulk Drugs (API)
• Drug intermediates
• Finished Pharmaceutical Formulations such as

• Tablets
• Capsules
• Liquid orals
• Injectables
• Topical
• Ophthalmic
• Nasal
• Inhalers and other products

CATEGORIES OF DRUGS TESTED

• Antibiotics
• Vitamins
• Steroids
• Hormones
• Analgesic / Antipyretic
• Dietary supplements (Vitamins & Minerals)
• Antacids
• Expectorants / Cough syrups
• Enzymes
• Antimalarial / Antiinfective
• Cardiovascular drugs
• Muscle relaxants / Rubefacients
• CNS Drugs
• Special Products
• Veterinary drugs

Other Products tested :

• Ayruvedic / Herbal Medicines
• Cosmetics
• Water as per BIS and Pharmacopeias
• Drug intermediates
• Excipients
• Fine Chemicals - Organic / Inorganic
• Pesticides Tech. / EC
• Alcohols
• Oils and fats
• Dye and Dye intermediates
• Food Colours.

TESTING HIGHLIGHTS

• Complete analysis as per various pharmacopeias
• Identification of various drugs
• Purity of pharmaceuticals
• Impurity profile
• Chromatographic purity / Related substances
• Organic
• Inorganic
• Organic Volatile impurities(OVI)
• Residual solvents
• Dissolution Profile
• Content Uniformity
• Chemical Safety Tests:

• Trace elements - Lead, Arsenic, Iron, Cadmium, Mercury, Selenium, Copper, Aluminum, Calcium, Barium, Strontium, Magnesium, Manganese, Titanium, Gold, Silver, Platinum, Palladium, Cobalt, Nickel, Boron, Sodium. Potassium, Chromium, Vanadium, Phosphorous, Sulphur, Zirconium, Rhodium, Lanthanum etc. by ICP/AAS

• Pesticide Residual analysis

• Aflatoxins - B1, B2, G1, and G2 in Bulk drugs and Formulations

• Method Validation by various analytical techniques

• HPLC / HPTLC / GC
• Chemical
• Microbiological
• ICP

Validation of Compendial Procedures-

Following parameters can be taken care of :

• Accuracy
• Precision
• Specificity
• Limits of Quantification
• Limit of Detection
• Linearity
• Range
• Robustness
• System suitability tests

• Method transfer data

• MICROBIAL TESTING

• Microbial limit tests

• Total bacterial count
• Yeast & mould
• Escherichia coli
• Salmonella
• Shigella
• Pseudomonas aeruginosa
• Staphylococcus aureus
• Enterobacteria
• Coliform
• Sulphite reducing bacteria
• Proteolytic/Lipolytic bacteria
• Clostridium perfringens
• Bacillus cereus
• Vibrio cholerae
• Vibrio parahaemolyticus
• Faecal coliform
• Faecal Streptococci

• Sterility
• Vitamin Assays
• Antibiotic Assays
• Water analysis
• Antimicrobial Preservative Efficacy test

• Bacterial Endotoxin test
• Pyrogen
• Undue toxicity

• STABILITY STUDIES AS PER ICH GUIDELINES
Complete Storage and testing.

• AYURVEDIC / HERBAL TESTING
• Identification
• Chemical analysis
• Microbial analysis
• Elemental analysis on ICP
• Purity /Impurity profile on HPTLC / HPLC
• Aflatoxins
• Pesticide Residues

Analytical Instrumentations :

• High Performance Liquid Chromatograph (HPLC)
• High Performance Thin Layer Chromatograph (HPTLC)
• Gas Liquid Chromatograph (GC)
• Inductively Coupled Plasma (ICP)
• Atomic Absorption Spectrophotometer (AAS)
• UV-Vis Spectrophotometer
• Fourier transform Infrared Spectrophotometer (FTIR)
• Automatic Protein Analyser
• Dissolution test apparatus
• Melt Flow Index

Lab Assurance
• Prompt service
• Quality Results