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 ITL Labs ?
Raw Materials
Finished Products
Oral Solids
- Tablets (coated and uncoated)
- Capsules (hard shell and soft shell)
- Powders
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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
- Liquids
- Gels
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Mechanical Contraceptives
- Condoms
- Tubal Rings
- Copper T
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Surgical items
- Sutures and ligatures
- Adhesive tapes
- Dressing and guages
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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 ITL Labs.
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.
ITL Labs 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
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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 |
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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 |
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Histamine like substances
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Intravenous injections |
What are the facilitites at ITL Labs ?
ITL Labs 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 ITL Labs for stability studies:-
ITL Labs has the complete arrangement to take up the studies for shelf life / stability as per the various laid down protocols. ITL Labs undertakes stability studies for all dosage forms.
Third Party Inspection
ITL Labs 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
ITL Labs has the capability to carryout Bioavailability studies for various drug molecules in all clinical samples like blood, plasma, urine etc.
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Healthcare Drugs Pharmaceutical and Cosmetics
Health Care