Catalogue · MA-CAT-2026
Tests & methods.
The complete list of analytical tests routinely performed at our Kwun Tong facility. Every entry names the technique, matrix, spec, standard turnaround, and the compendial reference we work to. Non-listed and custom methods are quoted on request.
§ PEP — Peptide & protein
Peptide & protein
Purity, identity, and sequence confirmation for synthetic peptides and small proteins.
PEP-01
Purity assay
Peptide API, lyophilised
RP-HPLC-UV, 214 / 254 nm
Spec — ≥ 0.05% area
48 hr
USP <621> · ICH Q6A
Request quote →PEP-02
Identity by intact mass
Peptide, ≥ 1 mg
LC-MS (ESI-TOF)
Spec — ±5 ppm vs. theoretical
48 hr
USP <1736>
Request quote →PEP-03
Sequence confirmation
Peptide, ≥ 2 mg
LC-MS/MS (HCD fragmentation)
Spec — ≥ 95% sequence coverage
5 days
USP <1055>
Request quote →PEP-04
Counter-ion content (TFA / acetate)
Peptide salt
IC / HPLC-CAD
Spec — 0.1–20% w/w
72 hr
Ph. Eur. 2.2.36
Request quote →PEP-05
Residual solvents
Peptide, API
GC-HS-FID
Spec — ICH Q3C class limits
72 hr
USP <467> · ICH Q3C(R8)
Request quote →PEP-06
Water content
Lyophilised peptide
Karl Fischer, coulometric
Spec — 0.01–15% w/w
24 hr
USP <921> · Ph. Eur. 2.5.32
Request quote →§ MET — Contaminants & heavy metals
Contaminants & heavy metals
Elemental impurity profiling and trace metals down to ppb-level detection.
MET-01
ICH Q3D elemental panel (24 elements)
API, excipient, finished product
ICP-MS with collision cell
Spec — PDE per Q3D Option 1
72 hr
ICH Q3D(R2) · USP <232> <233>
Request quote →MET-02
Extended trace metals (28 elements)
API, excipient, cosmetic
ICP-MS
Spec — LoQ 0.5–50 ppb
5 days
USP <233>
Request quote →MET-03
Residual catalyst screen (Pd, Pt, Ru, Rh)
API
ICP-MS, microwave digestion
Spec — LoQ 0.1 ppm
72 hr
ICH Q3D Table A.2.2
Request quote →MET-04
Speciation — inorganic vs. organic arsenic
Botanical, marine ingredient
HPLC-ICP-MS
Spec — LoQ 5 ppb
7 days
AOAC 2015.01
Request quote →§ MIC — Microbiological
Microbiological
Bioburden, sterility, endotoxin, and specified organism screening per USP compendial methods.
MIC-01
Total aerobic microbial count (TAMC)
Non-sterile product
Membrane filtration / plate count
Spec — Per USP <1111>
5 days
USP <61>
Request quote →MIC-02
Total combined yeasts & moulds (TYMC)
Non-sterile product
SDA, 22.5 °C, 5 d
Spec — Per USP <1111>
7 days
USP <61>
Request quote →MIC-03
Specified organisms screen
Non-sterile product
Selective enrichment + confirmation
Spec — Absence per 1 g / 10 g
7 days
USP <62>
Request quote →MIC-04
Bacterial endotoxin (LAL)
Parenteral, medical device rinsate
Kinetic chromogenic LAL
Spec — LoD 0.005 EU/mL
48 hr
USP <85> · Ph. Eur. 2.6.14
Request quote →MIC-05
Sterility (direct inoculation)
Sterile product
FTM + SCDM, 14 d incubation
Spec — No growth
14 days
USP <71>
Request quote →§ STB — Stability & shelf-life
Stability & shelf-life
ICH Q1A-aligned stability protocols. Real-time, accelerated, and forced-degradation studies with periodic pulls.
STB-01
Long-term stability (25 °C / 60% RH)
API, finished product
Programmed chamber, periodic pulls
Spec — Per protocol
Study-dependent
ICH Q1A(R2)
Request quote →STB-02
Accelerated stability (40 °C / 75% RH)
API, finished product
Programmed chamber, 0/1/3/6 mo pulls
Spec — Per protocol
6 months
ICH Q1A(R2)
Request quote →STB-03
Intermediate condition (30 °C / 65% RH)
Zone II/IVa product
Programmed chamber
Spec — Per protocol
Study-dependent
ICH Q1A(R2)
Request quote →STB-04
Forced degradation
API
Acid / base / oxidative / photo / thermal stress
Spec — Mass balance ± 5%
3 weeks
ICH Q1B · Q2(R1)
Request quote →STB-05
Photostability
API, drug product
ICH Option 2 light chamber
Spec — 1.2 M lux·h + 200 Wh/m² UVA
2 weeks
ICH Q1B
Request quote →§ MDV — Method development & validation
Method development & validation
Bespoke analytical methods for novel compounds, with full validation packages suitable for regulatory submission.
MDV-01
Full method validation package
Client-supplied API
Specificity, linearity, accuracy, precision, LoD/LoQ, robustness
Spec — Per ICH acceptance criteria
6–10 weeks
ICH Q2(R1)
Request quote →MDV-02
Method transfer
Client method + samples
Co-validation vs. originating lab
Spec — Pre-agreed acceptance
3–4 weeks
USP <1224>
Request quote →MDV-03
Method verification
Compendial method
Confirm suitability under lab conditions
Spec — System suitability
2 weeks
USP <1226>
Request quote →