Set up the comparison

Write the stereochemical form into the item name and acceptance documents. Cross-check it against the English name, identifier and analytical method.

Measurements to record

Stereochemistry (Chiral identification). Compare against a reference or under agreed optical rotation conditions. Record sample temperature and solvent. Principal component assay (% by mass). Identify the analyte, dry or as-received basis and method. Do not substitute a theoretical conversion for an incoming release result. Record the sample ID and method revision for repeat testing.

Interpreting the results

If a quote says only alanine, resolve the identity before approving a sample. Total assay alone does not distinguish L, D and DL material.

What to record

  • Stereochemistry
  • English name
  • Identifier
  • Analytical test
  • Approved sample revision

Technical references

Products and processes

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