Modi Laboratary

Drug,pharmaceuticals,cosmetic,herbel Products Testing

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
    Tablets (coated and uncoated)
    Capsules (hard shell and soft shell)
  • Parenteral products
  • Inhalation products
    Topical semi-solids
  • Topical Liquids and Powders
    Mechanical Contraceptives
    Tubal Rings
    Copper T
  • Oral Liquids
  • Aerosols
  • Rectal and vaginal products
    Ophthalmic Products
  • 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 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.

MODI 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
    Description Appearance, Colour, Odour, Shape
    Tensile Strength / Minimum breaking load
    Adhesive strength
    Scouring loss
    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
    Copper - T
Using Chemical / Instrumental Methods
  • Parameters
    Uniformity of weight / mass / volume / fill etc.
    Disintegration time
    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
    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.
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
    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.

    Intravenous injections

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.