Japanese Pharmacopoeia Chapter 9.62 – Requirements for Laboratory Weighing
Stricter regulations. Greater precision. Global alignment.
With the release of JP18 Supplement II, Chapter 9.62 of the Japanese Pharmacopoeia has been thoroughly updated—bringing it in line with international standards such as USP <41> and Ph. Eur. 2.1.7. For any pharmaceutical organisation operating in or exporting to Japan, these changes carry direct implications for how balances are selected, calibrated, and qualified.
What’s required under Chapter 9.62:
- Defined minimum weight (mₘᵢₙ) based on repeatability:
mₘᵢₙ = 2000 × s, or
mₘᵢₙ = 2000 × 0.41 × d when s < 0.41 × d. - Repeatability and sensitivity checks must be conducted regularly using test weights between 5%–100% of the balance’s capacity.
- Accuracy (trueness) must show ≤0.05% deviation between actual and indicated weight.
- Weights must be traceable to SI, and meet G1-7-182 standards for calibration uncertainty and Maximum Permissible Error (MPE).
- Use of Class F1 weights ≥ 500 mg is strongly recommended for sensitivity testing.
Key clarifications:
- Use Chapter 9.62 when traceability to SI is required;
Use Chapter G1-6-182 when traceability is not mandatory. - When weighing 15 mg, a 0.01 mg semi-micro balance is required—not a 0.1 mg analytical balance.
- The tare weight does not impact the minimum net sample weight—each sample must meet or exceed the minimum weight on its own.
Why it matters:
Whether you’re in Japan or exporting to it, compliance with Chapter 9.62 is legally binding and essential for GxP auditing, regulatory approval, and market access.
Download the full guide to ensure your lab meets the latest weighing requirements under JP Chapter 9.62.
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