Six tests, two laboratories, one release standard.

1. 01

   Identity

   Method

   ESI-MS (positive mode)

   Spec

   Observed mass within ±0.5 m/z of theoretical [M+H]

   Confirms the compound in the bottle is the compound on the label. Purity of the wrong molecule is still a failed batch.

2. 02

   Purity

   Method

   HPLC-UV, 220 nm (C18, 0.1% TFA gradient)

   Spec

   ≥ 98.0% area, internal release threshold 99.0%

   The number most buyers look for first. Titan publishes the exact run tied to the lot instead of a generic certificate library file.

3. 03

   Sterility

   Method

   USP <71> direct inoculation

   Spec

   No growth, 14 days, TSB + FTM

   Applied to nasal sprays and reconstituted liquids. The read is checked independently before release is signed.

4. 04

   Endotoxin

   Method

   LAL, kinetic chromogenic

   Spec

   < 5 EU/mg

   A clean chromatogram on a pyrogenic lot is still a failed batch. This filter separates a real QA operation from a cosmetic one.

5. 05

   Heavy metals

   Method

   ICP-MS (Pb, Cd, As, Hg)

   Spec

   Within ICH Q3D Option 1 limits

   Handled with an independent ISO 17025 partner. Titan does not fake owning instrumentation it does not operate in-house.

6. 06

   Residual solvents

   Method

   Headspace GC-FID

   Spec

   ICH Q3C class 2 solvents at report threshold

   DMF, methanol, acetonitrile, and related residue checks are screened and recorded on the retained lot documentation.