by maheshbhuva | Oct 23, 2026 | Analytical Chemistry, Pharmacopea
Pharmaceutical water—whether Purified Water (PW) or Water for Injection (WFI)—remains one of the most heavily scrutinized critical utilities during regulatory inspections.With ongoing harmonization across USP <1231>, Ph. Eur., and IP, reviewing analytical data... by maheshbhuva | Oct 9, 2026 | Analytical Chemistry, Pharmaceutical interview,, Quality control (QC)
Leveling Effect: Very weak basic drugs (e.g., diazepam, chlorpheniramine, ciprofloxacin) cannot be reliably titrated in water because water behaves as a stronger base than the analyte, causing poorly defined endpoints.Glacial Acetic Acid as Solvent: Glacial acetic... by maheshbhuva | Oct 9, 2026 | Analytical Chemistry, Titration
​Regulatory Driver: USP monographs, IP, and regulatory alerts require gas chromatography (GC-FID) limit tests for EG and DEG before release. ​Analytical Method: A capillary GC-FID method using a cyanopropylphenyl/dimethylpolysiloxane or polyethylene glycol phase... by maheshbhuva | Oct 3, 2026 | Analytical method development hplc,, Cleaning validation, Quality control (QC)
Product Quality Review (PQR / APQR) ​Answer: The PQR demonstrates the consistency of the commercial manufacturing process and the appropriateness of specifications. It must encompass: ​Review of raw materials and packaging materials (especially from new suppliers).... by maheshbhuva | Oct 2, 2026 | Analytical Chemistry, Pharmacopea, Quality control (QC)
Answer: A PQS establishes a state of control across the four product lifecycle stages (Development, Technology Transfer, Commercial Manufacturing, and Product Discontinuation). The four core enablers and management pillars are: ​Process Performance and Product Quality...