Quality assurance

Quality

Precision Compounds

Quality claims only mean something when they name a method and a limit. Across the catalogue, product documentation references recognised analytical methods and states numeric limits for the tests that matter to technical and compliance review.

Reference Precision Compounds

Documentation principle. Documents are published as supplied by the manufacturer. Nothing on this site strengthens, merges or extrapolates the statements inside them.

HPLC · ICP-MS · Microbiological testing · Residual solvents www.chemesis.com
Methods referenced

Each method maps to a decision

Where a specification cites a pharmacopoeial method, it is listed here with the role it plays in evaluation.

USP<621> 01

HPLC identification & assay

Used across botanical isolates and synthesized compounds for identity confirmation and assay.

USP<203> 02

HPTLC identification

Referenced for kava extract identification.

USP<730> 03

ICP-MS elemental contaminants

Lead, arsenic, cadmium and mercury limits.

USP<61> / <62> 04

Microbiological testing

Total plate count, yeast & mould, and specified absent organisms.

USP<467> 05

Residual solvents

Solvent residue requirements, with GC where stated.

USP<281> / <731> 06

Residue on ignition & loss on drying

Physical-chemical quality indicators.

USP<616> 07

Bulk density

Method I, where specified.

USP<786> 08

Particle size

Expressed as mesh throughput where specified.

USP<561> 09

Pesticide residue

Meets requirements where tested (modified method).

FCC VIII / USP 10

Identity — Sorbitol DC

Identification requirement for the direct-compression excipient grade.

Method references and limits vary by product. Confirm against the specification sheet and information package for the material you are reviewing.

Information package

What arrives with each documented product

The eighteen-page product information package aggregates the manufacturer statements procurement and compliance teams ask for, ahead of the safety data.

Statements are product-specific. They are issued per material and should not be assumed catalogue-wide.

  • 01 Allergen statement
  • 02 Manufacture flow chart
  • 03 Composition statement
  • 04 Gluten-free statement
  • 05 Non-GMO statement
  • 06 Country of origin
  • 07 Product tariff code
  • 08 Solvent statement
  • 09 BSE/TSE statement
  • 10 Intended use statement
  • 11 Irradiation & ETO-free statement
  • 12 Vegan / vegetarian statement
  • 13 Sterilization statement
  • 14 16-section Safety Data Sheet