Healthcare Drugs Pharmaceutical and Cosmetics

Healthcare Drugs Pharmaceutical and Cosmetics

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 ITL Labs ?

Raw Materials Oral Liquids
  • Syrup
  • Suspension
Finished Products
Oral Solids
  • Tablets (coated and uncoated)
  • Capsules (hard shell and soft shell)
  • Powders
Parenteral products
  • Injections
  • Implantations
Aerosols
  • Sprays
  • Foams
Inhalation products
  • Topical semi-solids
  • Creams
  • Gels
  • Poultices
  • Ointments
  • Pastes
Rectal and vaginal products
  • Suppositaries
  • Pessaries
  • Gels
  • Ointments
  • Creams
  • Solutions
  • Ophthalmic Products
  • Ointments
  • Liquids
  • Gels
Topical Liquids and Powders
Mechanical Contraceptives
  • Condoms
  • Tubal Rings
  • Copper T
Surgical items
  • Sutures and ligatures
  • Adhesive tapes
  • Dressing and guages

There are different sets of parameters for evaluating samples of different nature.

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 Applicability
Description Appearance, Colour, Odour, Shape 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 Applicability
Identification 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 Applicability
Microbiological assays Antibiotics, Vitamins
Sterility 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 Applicability
Pyrogen / Bacterial endotoxins 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 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.

We Serve Better Than Any Other!

ITL Labs provides state of the art services, both for quality assurance of Raw materials and finished products of various industries. Besides this, the expertise of ASD (Analytical services division) work as a support for regulatory authorities as well the consumers. The methods adopted are of International standards.