Drug Pharmaceuticals
Drugs, Pharmaceuticals, Cosmetics & Herbal Products
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 SRI ?
Raw Materials
Finished Products
◕ Oral Solids
- ▶ Powders
- ▶ Capsules (hard shell and soft shell)
- ▶ Tablets (coated and uncoated)
◕ Parenteral products
- ▶ Injections
- ▶ Implantations
◕ Inhalation products
- ▶ Pastes
- ▶ Ointments
- ▶ Poultices
- ▶ Gels
- ▶ Creams
- ▶ Topical semi-solids
◕ Topical Liquids and Powders
Mechanical Contraceptives
- ▶ Condoms
- ▶ Tubal Rings
- ▶ Copper T
◕ Oral Liquids
- ▶ Syrup
- ▶ Suspension
◕ Aerosols
- ▶ Foams
- ▶ Sprays
◕ Rectal and vaginal products
- ▶ Gels
- ▶ Liquids
- ▶ Ointments
- ▶ Ophthalmic Products
- ▶ Solutions
- ▶ Creams
- ▶ Ointments
- ▶ Pessaries
- ▶ Suppositaries
◕ Surgical items
- ▶ Sutures and ligatures
- ▶ Dressing and guages
- ▶ Adhesive tapes
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 Pharmacopoeiah
- ▶ 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 SRI.
What are the general methods followed for various drugs and pharmaceutical products ?e
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 ?e
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.
Modi Laboratory LABORATORY 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
- ▶ Pouch burst strength
- ▶ Pouch integrity
- ▶ Water leakage
- ▶ Burst volume and pressure test
- ▶ Friction force test
- ▶ Fracture test
- ▶ Absorbancy
- ▶ Scouring loss
- ▶ Adhesive strength
- ▶ Tensile Strength / Minimum breaking load
- ▶ Dimensions
- ▶ Description Appearance, Colour, Odour, Shape
◆ Applicability
- ▶ Copper - Th
- ▶ All raw materials and finished products
- ▶ Adhesive tapes, Dressing and guage, Sutures, Copper T,
- ▶ Tubal Rings, Condoms
- ▶ Coppr-T
- ▶ Condoms
- ▶ Adhesive tapes, Sutures, Copper-T
- ▶ Adhesive Tape
- ▶ Dressing and guage
- ▶ Tubal rings
Using Chemical / Instrumental Methods
◕ Parameters
- ▶ Identification
- ▶ Presence of Steroids
- ▶ Related substances
- ▶ Uniformity of Content
- ▶ Dissolution
- ▶ Disintegration time
- ▶ Uniformity of weight / mass / volume / fill etc.
◕ PH
- ▶ Presence of phytochemicals
◕ Presence of Alkaloids, Tannins
- ▶ Residual Solvents
- ▶ Particle Size
- ▶ Fatty acid and Esters
- ▶ Peroxide Value
- ▶ Acid Value
- ▶ Saponification value
- ▶ Organic volatile impurities
- ▶ Boiling point
- ▶ Melting point
- ▶ Refractive index
- ▶ Optical rotation
- ▶ Limit tests for heavy metals
◕ Applicability
- ▶ All raw materials and finished products
- ▶ Tablets, Capsules, Powders / Dry syrups Parenteral / Non
- ▶ parenteral
- ▶ formulations
- ▶ Tablets, Pessaries, Capsules
- ▶ Tablets, Capsules, Pessaries, Powders/ Dry Syrups,
- ▶ Injections, Oral liquids
- ▶ Injections, Tablets, Capsules, Powders/ Dry syrups, Oral
- ▶ liquids, Pessaries
- ▶ Ayurvedic medicines, other medicines
- ▶ Ayurvedic medicines and other herbal products
- ▶ Raw materials as well as finished products.
Using Microbiological Methods
◕ 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)
- ▶ Raw materials, Powders, Oral Suspensions, Creams, Ointments, Lotions, Topical Solutions, Empty Capsule Shells, Tablets
- ▶ Raw materials, Tablets, Capsules, Oral Suspensions
◕ Test Parameters
- ▶ Microbiological assays
- ▶ Sterility
- ▶ Microbial limit tests for Pathogenic organisms
- ▶ Lactic Acid Bacillus
Using Pharmacological Methods
◕ Test Parameters
- ▶ Pyrogen / Bacterial endotoxins
- ▶ Undue toxicity / abnormal toxicity
- ▶ Oxytocic activity
- ▶ Histamine like substances
◕ Applicability
- ▶ Parenteral preparations (Injections, Sterile preparations for injections)
- ▶ Systemic injection, intracutaneous injection, surgical items/
- ▶ medical devices, plastic containers / rubber closures.
What are the facilitites at Modi LABORATORY ?
Modi LABORATORY 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 Modi LABORATORY for stability studies:-
Modi LABORATORY has the complete arrangement to take up the studies for shelf life / stability as per the various laid down protocols. SRI undertakes stability studies for all dosage forms.
Third Party Inspection
Modi LABORATORY 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
Modi LABORATORY has the capability to carryout Bioavailability studies for various drug molecules in all clinical samples like blood, plasma, urine etc.