Reference standard in analysis of any new drugs

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REFERENCE STANDARD:

REFERENCE STANDARD Mr. Gitesh Patel GUIDE BY: Dr. P. Malairajan M. Pharm 1 st year

DEFINATIONS:

DEFINATIONS Drug Substance: These are new chemical entity(NCE) or the active pharmaceutical ingredient(API), in early phases of drug development consist consist of the following components: Active moiety Counter ion Water or solvent molecules (DS)

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Active Moiety: Drug Product: These is the pharmacologically active species. These are the finished product or finished dosage form , DS formulated with inactive ingredients (excipients) to appropriate delivary to human.

TYPES OF REFERENCE STANDARDS:

TYPES OF REFERENCE STANDARDS 1) Analytical Reference Standard (ARS) (Primary Standard / Gold standard) 2) Working Standard (WS) (Secondary Standard /In House Standard/ Laboratory Standard)

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ARS : It is defined as a batch of drug substance, whose purity is independently established & accepted without reference to other standard. (purity>99.5%) WS : It is used for routine analytical comparition of batches of API or dosage forms in cases where a high purity ARS is difficult to obtain. (purity > 95%)

Techniques Commonly Applied to the Qulification of Reference Standard:

Techniques Commonly Applied to the Qulification of Reference Standard 1. Appearance (physical description) a) Visual inspection b) Optical microscopy 2. Identification (proof of structure) a) Elemental analysis b) UV/Visible spectroscopy c) Infrared spectroscopy

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d) Raman spectroscopy e) X- ray diffraction f) Highresolution mass spectroscopy g) NMR spectroscopy h) Optical rotatory dispersion 3. Assay a) Titration b) Phase solubility analysis

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4. Purity a) Loss on drying b) Karl fischer titration c) Residue on ignition d) Thermogravimetry analysis f) HPLC g) Ion chromatography h) Electrophorotic separation i) Supercritical fluid chromatography j) TLC k) chiral chromatography l) Gas chromatography

Governance:

Governance The requirements for the laboratory control of reference standards was embedded in the Code of Regulations(CFR). Title 21 CFR Part 211 section 194 subsection 8b states “Complete records shall be maintained of any testing & standardization of laboratory reference standards, reagents, and standard solution.”

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Reference standards SOPs typically fall into two categories: a) Reference standard control & use procedures b) Reference standard qualification procedures.

Control & Use procedure:

Control & Use procedure A scope for the reference standards covered by the procedure has been identified. Proper documentation should be maintained for RS.(COA & qualification reports) RS entering into lab. with name, number, lot No.,storage condition,retest date & the analyst to whom the RS is assigned. All RS labeled with their identity, potency, correct use & storage condition. The RS is removed from lab & properly disposed on or before the date of requalification or expiry.

Qualificatin procedure:

Qualificatin procedure It state whats types of standards wiil be qualified according to procedure & which types of standards are excluded. Approved source for RS are identified. Analytical test for each RS. RS categorised for their use. Scientific defencible process for purity. Retest ,requalification & expiry are assigned. The test result recorded properly for regulatory agency. Potency of RS same up to expiry.

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THANK YOU