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 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... by maheshbhuva | Sep 29, 2026 | Analytical Chemistry, Analytical method development hplc,, Cleaning validation, Quality control (QC)
HBEL stands for Health-Based Exposure Limit. It is a scientifically and toxicologically derived value that represents the maximum daily dose of a substance (typically an active pharmaceutical ingredient, intermediate, or cleaning agent) to which an individual can be... by maheshbhuva | Jun 15, 2026 | Analytical Chemistry, Documents error (DIN), Out of specification, Pharmaceutical interview,, QMS, Quality control (QC)
RCA (ROOT CAUSE ANALYSIS) IN PHARMACEUTICAL INDUSTRIES AS PER REGULATORY REQUIREMENTS 1. PROBLEM IDENTIFICATION What Happens Clearly define the deviation, OOS, OOT, complaint, breakdown, audit observation, or incident. Includes Deviation description Date & time... by maheshbhuva | Jun 5, 2026 | Analytical Chemistry, Hplc
If you run high-performance liquid chromatography (HPLC) assay, you know that consistency is everything. In a validated method, your retention time (RT) should remain rock-steady from injection to injection. But every chromatographer eventually faces that frustrating...