Antibiotics and Drugs :: Delhi Test House

Drugs, Pharmaceuticals, Cosmetics & Herbal Products

The Company has complete in house facility to execute various jobs related to drugs, pharmaceuticals, cosmetics & herbal products

The section dealing with the drugs, pharma, cosmetics and herbal preparations focuses on the following as per DRUGS AND COSMETICS ACT 1945 AND THE RULES THEIR UNDER

Quality evaluation of Allopathic medicines
Quality evaluation of cosmetics/herbal cosmetics.
Quality evaluation of Ayurvedic medicines
Quality evaluation of Homeopathic medicines
Shelf life / Stability studies of pharmaceutical products at both ambient and accelerated conditions as per ICH guidelines
Inspection services

Requirement to analyze and certify drugs and pharmaceutical products as per DRUGS AND COSMETICS ACT 1945 AND THE RULES THEIR UNDER Analysis and certification of drugs and pharmaceuticals is necessary to ensure :

The conformity of healthcare products to the most critical standards of analysis. The chemical composition of the drugs to avoid any serious and adverse effects on human beings.

Type of Products Analyzed at DTH

Raw Materials
Biological & Non Biological includes antibiotics steroids Hormones and sex Hormones

Compressed Tables and Capsules Tablets (coated and uncoated) Capsules (hard gelatin and soft gelatin) Powders All type of veterinary products Injections and Eye/Ear Drops Small volume Injections (liquid and dry) Large volume injection Implantations and infusions Eye/ear drops All type of veterinary products Herbal and Medicated Cosmetics	Rectal and Vaginal Products Suppositories Pessaries Gels Ointments Creams Solutions Ophthalmic Products Ointments Liquids Aerosols Sprays Foams Topical Liquids and Powders	External Applications-Products Topical semi-solids Creams Gels Poultices Ointments Pastes Oral Liquid Syrup Powder for Suspension All type of veterinary products

DTH quality Norms and Protocols

Indian Pharmacopoeia
United States Pharmacopoeia
British Pharmacopoeia
British Herbal Pharmacopoeia
Ayurvedic Pharmacopoeia
Unani Pharmacopoeia
European Pharmacopoeia
Martindales Extra Pharmacopoeia
Any other protocol

In addition to this, products not listed in the pharmacopoeia are also analyzed by the methods developed by scientists of DTH.

General methods followed for drugs and pharmaceutical products

Physical, Chemical, Instrumental & Microbiological.

What are the test parameters evaluated by using different methods?

DTH has all the facilities to take up the analysis of the above test parameters in different products as mentioned below. Parameters other than purity are analyzed using different methods:

Physical, Chemical, Instrumental & Microbiological Methods

Parameters

Identification
Uniformity of weight / mass / volume / fill etc.
Disintegration time
Dissolution Rate test
Uniformity of Content
Related substances
Presence of Steroids
Acid Value

Limit tests for heavy metal

Optical rotation

Refractive index

Melting point

Boiling point

Organic volatile impurities

Saponification value

Particulate Matter

Peroxide Value

Fatty acid and Esters

Particle Size

Residual SolventsPh

Presence of phytochemicals

Presence of Alkaloids

Tannins

Iodine Value

Applicability

Tablets, Capsules, Powders
Dry syrups Parenteral / Non Parenteral Formulations
Tablets, Pessaries, Capsules
Injections, Oral liquids
Ayurvedic medicines, other medicines

Injections, Oral liquids

Ayurvedic medicines and other herbal products

Raw materials as well as finished products

Using Microbiological Methods

Parameters

Microbiological assays
Sterility
Microbial limit tests for Pathogenic organisms and their identifications
monitoring of Sterile Area and clean area for bio-burden//Bacterial Endo toxins (LAL Test)

Applicability

Antibiotics(B lactam, Non B Lactam & Cephalosporines)
Vitamins
Parenteral Preparations (Injections, Sterile Preparation for Injections)
Non Parenteral Preparations (Ophthalmic Solutions, eye drops, Eye ointments)
Surgical Dressing (Purified cotton, Gauge, Gauge-Bandage, Sutures, Catgut

Sterilized devices (Gloves, Blades, Disposable Syringes,
Needles, Transfusion and Infusion assemblies
Mechanical Contraceptives
Raw materials, Powders, Oral Suspensions, Creams,
Ointments, Lotions, Topical Solutions, Empty Capsule Shells, Tablets

Applicability

Parenteral preparations (Injections, Sterile preparations for injections)
Systemic injection, intracutaneous injection, surgical items/ medical devices, plastic containers / rubber closures
Intravenous injections

Facilitates at DTH

DTH is equipped with all facilities to take up the relevant test parameters for quality evaluation of different health care products. The details of the instruments are given in the list enclosed. The experts can not only develop validated methods for raw materials impurities and finished products but can also provide consultancy in the following areas:

Extraction of Herbal Products
Process Improvements
Product Differentiation.

Storage / Stability Studies of Drugs and Pharmaceutical Products

Shelf life refers to the period from initial preparation and packaging up to expiry date during which the drug dosage form continues to remain within its physical, chemical, and toxicological specifications at specified storage conditions. The product must retain the labeled claim weel within the limit mentioned for speified products under drug act and related Pharmacopoeia.

As per USP; 4 types of stability studies:

Chemical, Physical, Microbiological, Toxicological

Factors affecting Stability

Environmental factors
Temperature
Light
Air
Oxygen
Moisture
Carbon dioxide

Other ingredients or excipients in the dosage form

Particle size of drug

pH of the vehicle

Microbial contamination

Trace metal Contamination

Leaching from containers

Condition of stability testing conduction

Shelf life storage stability
Accelerated conditions
Controlled room temperature conditions
Product samples are analyzed at various intervals by validated analytical methods

Third Party Inspection

DTH undertakes third party inspection and testing of pharmaceutical supplies to various State Government Health Departments. The team of experts can undertake the inspection of different drugsandpharmaceuticalProducts.