Chemistry/Drug Testing

Introduction:

The chemistry section is well equipped with many modern sophisticated instruments like Ultra Violet Spectrophotometer, Atomic Absorption Spectrophotometer, and HPTLC etc. Section actively engaged in the standardization of Homoeopathic drugs by using modern analytical techniques. Section also engaged in the testing of Homoeopathic drugs viz. Mother Tincture, Potency, Tablets, Bio-chemic, Eye drops, Syrup, Ointment etc received from various sources like Government Drug Controlling Authorities.

Testing Parameter in Homoeopathic Medicine:

Mother Tinctures: Determination of

  1. Alcohol Content in %
  2. pH value
  3. Specific gravity
  4. Total Solids in %
  5. λ – max by UV Spectrophotometer
  6. Identification of Active Principle present in the Drug.

Potencies/ Dilution:Determination of

  1. Alcohol Content in %
  2. Absence of Fusel Oil
  3. Absence of adehydes & ketones
  4. Drug content up to 3x Level

Biochemic Tablet: Determination of

  1. Disintegration / Dissolution time
  2. Test for lactose
  3. Percentage of Ash value w/w
  4. Identification of Drugs up to 3x.

Ointments:Determination of

  1. Consistency & Homogenicity
  2. Base material
  3. Drug Content
  4. Identification of claimed drug

Hair Oil: Determination of

  1. Test for base oil
  2. Identification of drug
  3. Determination of Acid value
  4. Determination of Iodine value
  5. Determination of Saponification value

Formulations: The formulations are tested as per label claim

Services provided by Chemistry section:

Drug Testing Section provides following services –

  • Testing of homoeopathic drugs received from Drug Control Authorities, Port Authorities, Central & State Govt. supply etc for their quality as per standard mentioned in Homoeopathic Pharmacopoeia and as per rules under Drug & Cosmetic Act.
  • Preparation and Standardization of homoeopathic drugs.
  • Finish Product standardization for homoeopathic drugs.

Facilities Available:

Drug Testing Section provides following facilities-

  • HPTLC Finger Printing
  • Physicochemical standardization of raw drugs.
  • Heavy metal detection through Atomic Absorption Spectrophotometer.
  • Purity and concentration of alcohol.
  • Others instruments: ph Meter, Water-bath, Electric Bunsen , Moisture Analyzer, Refractometer, Polarimeter, UV Spectrophotometer etc.

Act & Rules regarding homoeopathic drugs:

Act & Rules regarding homoeopathic drugs
Title Details
Part IV-A Import and Registration
30-AA : Import of New Homoeopathic Medicines
32-A : Packing and labeling of Homoeopathic Medicines.
Part VI-A 67-C to 67-H Sale of Homoeopathic Medicines.
Part VII-A 85-A to 85-I Manufacture for sale or for distribution of
Homoeopathic Medicines.
Part IX-A Labeling and Packing of Homoeopathic Medicines
106A: Manner of labeling of Homoeopathic medicines
106B: Prohibition of quantity and percentage.
Part XII Standards
126-A: Standards of ophthalmic preparations including Homoeopathic ophthalmic preparations.
Schedule FF Standards of ophthalmic preparations including Homoeopathic ophthalmic preparations.
Schedules M-I Good Manufacturing Practices and requirement of premises, Plant and equipment.

Online Drug testing module:

  1. Sealed samples are to be sent along with duly filled Form ‘18’ for Drug Control Authority or Form ‘1’ for Port Authority whichever is applicable as per Drug & Cosmetic Act and certificate of analysis test report by Government Analyst send through Form ‘13’ for Drug Control Authority & Form ‘2’ for Port Authority.
  2. Individual drug testing sample is received for testing through form ‘14 A’ and certificate of analysis test report send through Form ’14 B’.
  3. After receiving the testing fees, the certificate of analysis test reports is sent to the concerned Drug Authorities. For Advance payment is made through online mode go to through Non Tax Receipt Portal (www.bharatkosh.gov.in).