Drugs, Pharmaceuticals, Cosmetics & Herbal Products

Health Care

The section dealing with the drugs, pharma, cosmetics and herbal preperations 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
  Tablets (coated and uncoated)
  Capsules (hard shell and soft shell)
  Powders
• Parenteral products
  Injections
  Implantations
• Inhalation products
  Topical semi-solids
  Creams
  Gels
  Poultices
  Ointments
  Pastes
• Topical Liquids and Powders
  Mechanical Contraceptives
  Condoms
  Tubal Rings
  Copper T

• Oral Liquids
  Syrup
  Suspension
• Aerosols
  Sprays
  Foams
• Rectal and vaginal products
  Suppositaries
  Pessaries
  Gels
  Ointments
  Creams
  Solutions
  Ophthalmic Products
  Ointments
  Liquids
  Gels
• Surgical items
  Sutures and ligatures
  Adhesive tapes
  Dressing and guages

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 SRI.

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.

J.K.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 analyse using different methods :

• Test Parameters
  Description Appearance, Colour, Odour, Shape
  Dimensions
  Tensile Strength / Minimum breaking load
  Adhesive strength
  Scouring loss
  Absorbancy
  Fracture test
  Friction force test
  Burst volume and pressure test
  Water leakage
  Pouch integrity
  Pouch burst strength

• Applicability
  All raw materials and finished products
  Adhesive tapes, Dressing and guage, Sutures, Copper T, Tubal Rings, Condoms
  Adhesive tapes, Sutures, Copper-T
  Adhesive Tape
  Dressing and guage
  Dressing and guage
  Tubal rings
  Tubal rings
  Condoms
  Condoms
  Coppr-T
  Copper - T

• Parameters
  Identification
  Uniformity of weight / mass / volume / fill etc.
  Disintegration time
  Dissolution
  Uniformity of Content
  Related substances
  Presence of Steroids
• pH
  Presence of phytochemicals
• 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

• Applicability
  All raw materials and finished products
  Tablets, Capsules, Powders / Dry syrups Parenteral / Non parenteral
  formulations
  Tablets, Pessaries, Capsules
  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
  Injections, Oral liquids
  Ayurvedic medicines and other herbal products
  Ayurvedic medicines and other herbal products.
  Raw materials as well as finished products.

• 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

• 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.
  
  Intravenous injections

What are the facilities at J.K. LABORATORY ?

J.K.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

• 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