中文
（Nanjing Meidong Hanwei Technology Co., Ltd.）
Nanjing Meidong Hanwei Technology Co., Ltd. was established in July 2007 and is located at No. 64 Suning Avenue, Xuanwu District, Nanjing. In March 2020, the company established a management system based on CNAS-CL01:2018 "Accreditation Criteria for the Competence of Testing and Calibration Laboratories" (ISO/IEC 17025:2017) and relevant accreditation requirements, incorporating the actual conditions of the company, which covers the requirements of the accreditation criteria. In August 2021, it obtained the CNAS accreditation qualification, with 65 accredited items, 132 testing methods, and it conducts tests according to the standards of the "Chinese Pharmacopoeia", "United States Pharmacopeia-National Formulary", "European Pharmacopoeia", and "Japanese Pharmacopoeia". It mainly engages in the inspection and testing services of pharmaceutical excipients, including sample testing, method development, method validation, and technical consultation.
The testing center currently has over 30 employees and occupies an area of approximately 1,200 square meters, equipped with more than 70 sets of instruments and equipment. It consists of the Testing Room, Microbiology Room, and Comprehensive Management Room. The main testing equipment configured by the company includes: gas chromatographs, liquid chromatographs, GC-MS (gas chromatography-mass spectrometry), LC-MS (liquid chromatography-mass spectrometry), UV spectrophotometers, infrared spectrometers, inductively coupled plasma optical emission spectrometers, Kjeldahl nitrogen analyzers, biological safety cabinets, pulsating vacuum sterilizers, ultra-low temperature freezers, and other precision instruments.
The company relies on professional instruments and equipment, utilizes scientific and standardized testing methods, and maintains an objective and fair attitude to provide users with accurate testing data, authoritative testing conclusions, and high-quality professional services. The company is committed to the satisfaction of its customers, continuously improving its management system and enhancing its testing capabilities to ensure the provision of timely and accurate testing services.
Phone: 025-58370252
Email: ghl @wellnj.com
number | object name | Parameter | method | According to the standard |
1 | Chemical drugs | Identification | Infrared Spectrophotometry | EP11.0 |
Thin-layer Chromatography | EP11.0 | |||
Infrared Spectrophotometry | USP-NF | |||
Chromatography | USP-NF | |||
Infrared Spectrophotometry | JP18 | |||
Related Substances | Ultraviolet - Visible Spectrophotometry | EP11.0 | ||
Thin-layer Chromatography | EP11.0 | |||
Gas | EP11.0 | |||
Chromatography | USP-NF | |||
Assay | Gas Chromatography | ChP2020 Vol.Ⅳ General Chapters | ||
Potentiometric Titration and Dead-stop Titration | ChP2020 Vol.Ⅳ General Chapters | |||
Gas | EP11.0 | |||
High Performance Liquid Chromatography | EP11.0 | |||
Chromatography | USP-NF | |||
Nitrogen | Nitrogen Determination | USP-NF | ||
Relative density | Relative density | EP11.0 | ||
Specific Gravity | USP-NF | |||
Freezing point | Freezing point | EP11.0 | ||
Determination of Congealing point | JP18 | |||
Optical rotation | Specific optical rotation | EP11.0 | ||
Optical Rotation | USP-NF | |||
Optical Rotation Determination | JP18 | |||
Refraction rate | Refractive index | EP11.0 | ||
Refractive Index | USP-NF | |||
pH value | pH | USP-NF | ||
pH Determination | JP18 | |||
Viscosity | Viscosity Determination | EP11.0 | ||
Viscosity | USP-NF | |||
Acid value | Fats and Fixed Oils | USP-NF | ||
Hydroxyl value | Tests of Fats and Fatty oils | ChP2020 Vol.Ⅳ General Chapters | ||
Fats and Fixed Oils | USP-NF | |||
Peroxide value | Fats and Fixed Oils | USP-NF | ||
Saponification value | Fats and Fixed Oils | USP-NF | ||
Fatty acid composition | Fats and Fixed Oils | USP-NF | ||
Fluoride | CHLORIDE AND SULFATE | USP-NF | ||
Sulfate | CHLORIDE AND SULFATE | USP-NF | ||
Heavy metal | Heavy Metals Limit Test | JP18 | ||
Loss on Drying | Determination of Loss on Drying | ChP2020 Vol.Ⅳ General Chapters | ||
LOSS ON DRYING | USP-NF | |||
Loss on Drying Test | JP18 | |||
Water | Water: Semi-Micro Determination | EP11.0 | ||
Heavy metal | USP-NF | |||
Residue on ignition | Sulfated ash | JP18 | ||
RESIDUE ON IGNITION | USP-NF | |||
Residue on Ignition Test | JP18 | |||
Solution color | Degree of coloration of liquids | EP11.0 | ||
Clarification degree | Degree of coloration of liquids Clarity and degree of opalescence of liquids | EP11.0 | ||
Microbial limit | Microbiological examination of non-sterile products: microbial enumeration tests | EP11.0 | ||
MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS | USP-NF | |||
MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: TEST FOR SPECIFIED MICRO-ORGANISMS(3) | EP11.0 | |||
MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS | USP-NF | |||
Microbiological Examination of Non-sterile Products | JP18 | |||
Bacterial endotoxin | Bacterial endotoxins | EP11.0 | ||
Bacterial Endotoxins Test | USP-NF | |||
Bacterial Endotoxins Test | JP18 | |||
Molecular weight and distribution | Molecular exclusion chromatography | ChP2020 Vol.Ⅳ | ||
ash content | ash content | ChP2020 Vol.Ⅳ | ||
| Appearance | Page ⅪChP2020 Vol.Ⅳ | ||
Solubility | Solubility | Page ⅪChP2020 Vol.Ⅳ |
WeChat Official Account
Building 5, R&D Zone 5, No. 64 Suning Avenue, Xuanwu District, Nanjing, China
025-83172922 025-85310306
wellyy@njwell.com
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