Services | Beijing ZKGX Research Institute

Acute dermal toxicity testing to OECD 402, OPPTS 870.1200 and GB/T 21606-2022: fixed-dose procedure, limit test, GHS Categories 1-5, and the >98% waiver criteria.

152

Acute Eye Irritation Test

Acute eye irritation test for medical devices to GB/T 16886.23-2023 / ISO 10993-23 and for chemicals to OECD 405: extract preparation, Draize scoring, and 6 in-vitro methods.

153

Wire Tensioner Testing Explained

Wire tensioner testing to DL/T 875, DL/T 2131 and GB 12167: rated load, 1.25× overload proof, 3× breaking-force safety factor, and 60-second jaw slip test.

154

Pressure Sensor Testing & Calibration

Pressure sensor testing to JJG 882 and IEC 60770: accuracy classes and MPE, test-point and cycle rules, the 1/3 reference-standard rule, and certificate contents.

155

Ultrasound Probe Testing

Ultrasound probe testing: six image-quality QA tests with pass criteria, IEC 60601-2-37 / 62353 / 62359 safety and acoustic output standards, and repair validation.

156

Salt spray test

Salt spray test (ASTM B117 / ISO 9227): NSS conditions, AASS/CASS variants, ASTM G85 annexes, coating hour benchmarks, and how results are rated.

157

Soybean Lecithin Testing

Soybean lecithin testing explained: AOCS Ja methods, JECFA INS 322 and GB 1886.358-2022 thresholds for AI, acid value, peroxide and HPLC phospholipid profile.

158

glucocorticoid testing

Glucocorticoid API testing per USP / EP / Chinese Pharmacopoeia: assay 96-104% HPLC-UV, related substances, C-21 oxidation degradation, residual solvents ICH Q3C, elemental Pd ICH Q3D. CMA/CNAS.

159

Radiated emission testing

Radiated emission testing per CISPR 32 / GB 9254 / FCC Part 15 / EN 55032: semi-anechoic chamber, 30 MHz-6 GHz, Class A/B limits, biconical horn antenna, peak quasi-peak. CMA/CNAS.

160

Immunological evaluation

Immunological evaluation per ISO 10993-10 / -20 / GB/T 16886.10/.20: GPMT, LLNA, RhE in vitro, DPRA KeratinoSens h-CLAT, 28-day immunophenotyping, FDA vs EU. CMA/CNAS.

161

propyl gallate testing

Propyl gallate (E310) testing per USP / FAO JECFA INS 310 / EU 1333/2008 / GB 1886: assay 98.5% HPLC-UV, gallic acid impurity, ADI 0.5 mg/kg, heavy metals. CMA/CNAS.

162

Hollow Capsule Testing

Hollow capsule testing per Chinese Pharmacopoeia / USP / EP: disintegration 10 min, LOD 12.5-17.5%, chromium 2 ppm GFAAS, heavy metals 30 ppm, microbial limits, gelatin vs HPMC. CMA/CNAS.

163

maltitol testing

Maltitol testing per FAO JECFA INS 965 / USP Maltitol Solution / EU E 965: assay 98% HPLC-RI, specific rotation +105-108, nickel 2 ppm, DEG EG 0.10%, reducing sugars. CMA/CNAS.

164

Trehalose Testing per USP Monograph

Trehalose testing per USP Trehalose / EP 2805 / GB 1886 / pharmacopoeia: assay 97-102% HPLC-RI, water KF, specific rotation +197-201, endotoxin 0.25 EU/mg. CMA/CNAS.

165

benzo[a]pyrene testing

Benzo[a]pyrene testing per GB 5009.265 / EU 1881/2006 / EPA 8270: 16 PAH panel, PAH4, BaP equivalents PEFs, HPLC-FLD GC-MS, oils BaP 2 ug/kg PAH4 10 ug/kg. CMA/CNAS.

166

Surgical Shadowless Lamp Testing

Surgical shadowless lamp testing per YY 9706.241-2020 / IEC 60601-2-41: illuminance 40-160 klux, shadow dilution, CRI R9, color temperature, irradiance 1000 W/m2, IP54, GB 9706.1. CMA/CNAS.

167

Polysaccharide Testing per SN/T 4260

Polysaccharide testing per SN/T 4260 / GB 16740: phenol-sulfuric acid total content, HPGPC-MALS molecular weight, PMP-HPLC monosaccharide composition, beta-glucan, NMR. CMA/CNAS.

168

Povidone Testing per USP Monograph

Povidone (PVP) testing per USP Povidone / EP 0691 / GB 31630 / FAO JECFA: K-value Fikentscher, nitrogen 11.5-12.8%, 2-pyrrolidone, hydrazine 1ppm, peroxides. CMA/CNAS.

169

Anthocyanin Testing

Anthocyanin testing per GB 5009.185 / AOAC 2005.02 / EU E163: 6 anthocyanidin aglycones, pH differential method, HPLC-MS/MS fingerprint, authenticity, stability. CMA/CNAS.

170

IEC 61000-4-2 ESD Immunity Test

IEC 61000-4-2 / GB/T 17626.2 ESD immunity test: 4 levels (2-8 kV contact, 2-15 kV air), 150 pF/330 ohm, waveform, HCP/VCP, criteria A/B/C, Annex B calibration. CMA/CNAS.

171

Vaccine Virus Inactivation Testing

Vaccine virus inactivation testing per WHO TRS / NMPA: formaldehyde, BPL, BEI concentration <=0.1%, complete inactivation verification, kinetics, antigenicity. CMA/CNAS.

172

Disinfectant Virucidal Testing

Disinfectant virucidal testing per EN 14476 / EPA 810.2200 / GB 27953: >=4 log reduction, MVA/AdV-5/MNV/Polio virus panel, 2025 GDA PAA, suspension+carrier. CMA/CNAS.

173

Viral Clearance Testing

Viral clearance testing per ICH Q5A(R2) / NMPA: XMuLV PRV MMV model virus panel, log reduction factor, low pH/nanofiltration, NGS, AAV VLP. CMA/CNAS lab.

174

pectin testing

2026-06-23

Pectin testing per FAO JECFA / FCC / GB 25533: galacturonic acid 65%, DE/DV HM-LM, E 440(i)/(ii), SAG gel grade, residual solvents, SO2, GMP. CMA/CNAS lab.

175

Hearing aid testing

2026-06-23

Hearing aid testing per ANSI S3.22 / IEC 60118 / GB/T 25102.7: OSPL90 110-135 dB, HFA, FOG, RTG, T-coil, EMC, ISTS, FDA OTC 2022 rule. CMA/CNAS lab.