Drugs Frama pharmaceuticals consmetics herbal product
Health Care
The section dealing with the drugs, pharma, cosmetics and herbal preprations focuses on the following thrust areas:
» Quality evaluation of Allopathic medicines
» 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
Why is it necessary to analyze and certify drugs and pharmaceutical products ?
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.
What are the general nature of pharmaceutical samples taken for analysis at CHEMRTL ?
| Oral Solids Tablets (coated and uncoated) Capsules (hard shell and soft shell)Powders | Oral Liquids SyrupSuspension |
| Parenteral products InjectionsImplantations | Aerosols SpraysFoams |
| Inhalation products Topical semi-solids Creams Gels Poultices Ointments Pastes Topical Liquids and Powders | Rectal and vaginal products Suppositaries Pessaries Gels Ointments Creams Solutions Ophthalmic Products Ointments LiquidsGels |
| Mechanical Contraceptives Condoms Tubal RingsCopper T | Surgical items Sutures and ligatures Adhesive tapes Dressing and guages |
There are different sets of parameters for evaluating samples of different nature.
What are the quality Norms and Protocols followed for analysis?
Analysis is done as per both National and International Standards with following major 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 analysed by the methods developed by scientists of CHEMRTL .
What are the general methods followed for various drugs and pharmaceutical products ?
The general methods for various drugs and pharmaceutical products are as follows:
» Physical
» Chemical
» Instrumental
» Microbiological
» Pharmacological
What are the test parameters evaluated by using different methods ?
In order to ensure the right quality of the products, besides testing for the active ingredients, it is also necessary to test several other parameters. For each parameter the protocols/validated methods are used. Following list gives the details of the parameters other than purity and their methods.
CHEMRTL 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 analysed using different methods : Using Physical Methods :
Test Parameters Description Appearance, Colour, Odour, Shape | Applicability All raw materials and finished products |
| Dimensions | Adhesive tapes, Dressing and guage, Sutures, Copper T, Tubal Rings, Condoms |
| Tensile Strength / Minimum breaking load | Adhesive tapes, Sutures, Copper-T |
| Adhesive strength | Adhesive Tape |
| Scouring loss | Dressing and guage |
| Absorbancy | Dressing and guage |
| Fracture test | Tubal rings |
| Friction force test | Tubal rings |
| Burst volume and pressure test | Condoms |
| Water leakage | Condoms |
| Pouch integrity | Coppr-T |
| Pouch burst strength | Copper – T |
Using Chemical / Instrumental Methods
Parameters Identification | Applicability All raw materials and finished products |
| Uniformity of weight / mass / volume / fill etc. | Tablets, Capsules, Powders / Dry syrups Parenteral / Non parenteral |
| Disintegration time | formulations |
| Dissolution | Tablets, Pessaries, Capsules |
| Uniformity of Content | Tablets, Pessaries, Capsules |
| Related substances | Tablets, Capsules, Pessaries, Powders/ Dry Syrups, Injections, Oral liquids |
| Presence of Steroids | Injections, Tablets, Capsules, Powders/ Dry syrups, Oral liquids, Pessaries |
| pH | Ayurvedic medicines, other medicines |
| Presence of phytochemicals | Injections, Oral liquids |
| Presence of Alkaloids, Tannins – Limit tests for heavy metals – Optical rotation – Refractive index – Melting point – Boiling point – Organic volatile impurities – Saponification value – Acid Value – Peroxide Value – Fatty acid and Esters – Particle Size Residual Solvents | Ayurvedic medicines and other herbal products Ayurvedic medicines and other herbal products. Raw materials as well as finished products. |
Using Microbiological Methods
Test Parameters Microbiological assays Sterility | Applicability Antibiotics, Vitamins Parentaral Preparations (Injections, Sterile Preparation for Injections) Non Parentaral Preparations (Opthalmic Solutions, eye drops, Eye ointments) Surgical Dressing (Purified cotton, Guage, Guage-Bandage, Sutures, Catgut) Sterilized devices (Gloves, Blades, Disposable Syringes, Needles, Transfusion and Infusion assemblies, Mechanical Contraceptives) |
| Microbial limit tests for Pathogenic organisms | Raw materials, Powders, Oral Suspensions, Creams, Ointments, Lotions, Topical Solutions, Empty Capsule Shells, Tablets |
| Lactic Acid Bacillus | Raw materials, Tablets, Capsules, Oral Suspensions |
Using Pharmacological Methods
Test Parameters Pyrogen / Bacterial endotoxins | Applicability Parenteral preparations (Injections, Sterile preparations for injections) |
| Undue toxicity / abnormal toxicity | Systemic injection, intracutaneous injection, surgical items/ medical devices, plastic containers / rubber closures. |
| Oxytocic activity | |
| Histamine like substances | Intravenous injections |
What are the facilitites at CHEMRTL ?
CHEMRTL is equipped with all facilities and has an animal house 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.
Shelf Life / Stability Studies of Drugs and Pharmaceutical Products
What is Shelf life in case of Health Care Products ?
Shelf-life refers to the period from initial preparation and packaging during which the drug dosage form continues to remain within its physical, chemical, therapeutic and toxicological specifications at specified storage conditions.
The product must retain 90% of the labeled claim at the end of shelf-life.
What does stability mean for drugs and pharmaceuticals ?
The stability of the product is its ability to resist deterioration. It is always expressed in terms of shelf life.
As per USP there are five types of stability studies :
» Chemical
» Physical
» Microbiological
» Therapeutic
» Toxicological
What are the factors affecting Stability ?
The various factors affecting pesticides stability are :
» Environmental factors
» Temperature
» Light
» Air
» Oxygen
» Moisture
» Carbondioxide
» Other ingredients or excipients in the dosage form
» Particle size of drug
» pH of the vehicle
» Microbial contamination
» Tracemetal Contamination
» Leaching from containers
When do we need stability testing ?
How are the stability tests conducted ?
» Studies are conducted at
» Accelerated conditions
» Controlled room temperature conditions
» Product samples are analyzed at various intervals by validated analytical methods
Facilities at CHEMRTL for stability studies:-
CHEMRTL has the complete arrangement to take up the studies for shelf life / stability as per the various laid down protocols. CHEMRTL undertakes stability studies for all dosage forms.
Third Party Inspection
CHEMRTL 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 drugs and pharmaceutical.products.
Bioavailability studies
CHEMRTL has the capability to carryout Bioavailability studies for various drug molecules in all clinical samples like blood, plasma, urine etc.