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1. HANDLING OF
REFERENCE STANDARDS
LIM WEN JUN
PRODUCT AND COSMETIC TESTING SECTION

2. Outline
1 Definition
2 Classification
3
Establishments – CoA, Validity,
Storage Condition & Safe Handling
4 Case Study
Lovastatin in Chemical Analysis Unit (Traditional & Cosmetic)

3. Reference Standard = Reference Substance = Reference Material
• A certified, uniform / homogenous material that is intended for use
in specified tests;
• Possesses a degree of purity adequate for its intended use.
• Its properties are compared with those product under
examination (i.e. test sample)
REFERENCE STANDARDS ??

4. CLASSIFICATION
OF REFERENCE STANDARDS
Primary
RS
Secondary
RS
In-house reference
standards

5. Primary Reference Standard
• Pharmacopeial Reference Substance
• Internationally accepted as having appropriate qualities within a specified
context and whose value is accepted without reliance on comparison to
other reference material.
• Established and distributed by pharmacopoeial authorities following the
general principles of ISO Guide 34 for Reference Material Producers
(RMP).
• Pharmacopoeial authorities e.g. USP, BP, EP
CLASSIFICATION

6. Secondary Reference Standard
• Working Standard
• Substance whose characteristics are assigned and/or calibrated by
comparison with a primary standard
• The extent of characterization and testing may be less extensive.
• Traceable to primary standard
• ASEAN RS, Sigma-Aldrich etc
CLASSIFICATION

7. In House Reference Standard
• Reference standard that was manufactured, purified and fully
characterized and structurally elucidated.
• Use for routine laboratory work, in the analysis of production batches of
new drug substance or drug products (NCE).
CLASSIFICATION

8. Applications
Quantitative Tests
• Assay
• Impurity Tests
Qualitative Tests
• Identification Tests
Equipment Calibrations

9. Certificate of Analysis
 Name of reference substance
 Batch / control number
 Description of the physical nature of the reference substance
 Tests carried out together with the results
 Intended use of the reference substance
 Direction for use (e.g. instruction on drying before use)
 Recommended storage conditions

10. Certificate of Analysis

14. Certificate

16. Validity
• Quality & Stability over time
• ALWAYS check BEFORE using

17.  Follow recommended storage condition
 Avoid high temperatures
 Avoid light
• Amber glass
 Prevent contamination
 Avoid humidity
• Store in dry location such as a desiccator
Good Practices for Storage

19. Why proper storage?

20.  Good Practices for personnel protection
 Wear appropriate Personal Protective Equipment (PPE):
 Gloves,respirator,etc
 Long sleeves or lab coat
 Closed-toe shoes
 Check handling precautions for specific compounds (MSDS)
 Check label properly
 Check CoA and purity
 Store in proper environment and seal with parafilm
Proper Handling

21. Handling of Lovastatin RS
In Traditional & Cosmetic Subunit

22. TRC
USP

23. Thank you