XHIGH ULTRA CHINA TOP 1000

Сегменты

Одна компания может относиться к нескольким сегментам.

API, интермедиаты и CDMO

Global API & Biosimilars QC Suite World API Extension QC Suite Ферментация и антибиотические интермедиаты Lumex QC Suite

Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Elemental Impurities ICP Quality Checker LC-MS Confirmation Quality Checker Method Validation Data Packager Process Validation Checker Change Control Impact Checker

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IVD и диагностика

Medical Devices / стандарты и lifecycle QC Medical Device Software Medical Device Risk Management

Companion Diagnostic Report Checker Requirement Traceability Checker Software Safety Class Checker Integration Test Coverage Checker Data Integrity Security Checker Cybersecurity Risk Assessment Checker Electrical Safety Test Summary Checker EMCTest Coverage Checker

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OTC и consumer health

Китай: пакет утилит по национальному списку основных лекарств Global API & Biosimilars QC Suite

Assay & Impurity HPLC Quality Checker Dissolution Apparatus 1 & 2 Quality Checker Content Uniformity Quality Checker Microbial Enumeration (TAMC/TYMC) Quality Checker Specified Microorganisms Quality Checker Stability Condition Monitoring Quality Checker Packaging Integrity Checker Supplier Evaluation Checker

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TCM и растительные препараты

Herbal / TCM / Ayurveda instrumental QC British Herbal Pharmacopoeia QC Suite Китай: пакет утилит по национальному списку основных лекарств

Chromatographic Fingerprint Similarity Checker Herbal Chromatographic Fingerprint Analyzer Herbal Multi Component Assay Checker TCMDecoction Consistency Checker Herbal Pesticide Residue Checker Herbal Mycotoxin Limit Checker Herbal Heavy Metals Screening Checker Herbal Extract Solvent Residue Checker

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Антибиотики и ферментация

Ферментация и антибиотические интермедиаты Global API & Biosimilars QC Suite

Antibiotic Intermediate Release Checker Antibiotic Potency Assay Checker Fermentation Impurity Profile Analyzer Fermentation Residual Solvent Checker Fermentation Bioburden Trend Checker Fermentation Yield Consistency Checker Six APAImpurity Profile Checker Seven ACAImpurity Profile Checker

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Антималярийные препараты

Global API & Biosimilars QC Suite Herbal / TCM / Ayurveda instrumental QC

Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Herbal Heavy Metals Screening Checker Herbal Pesticide Residue Checker Stability Condition Monitoring Quality Checker

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Базовый фармацевтический контур

Китай: пакет утилит по национальному списку основных лекарств Lumex QC Suite LabEx QC Suite Medical Device QMS

Assay & Impurities Result Reviewer Release Readiness Checker Genotoxic Impurity Screener M7 Content Uniformity Acceptance Value Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker System Suitability Parameters Checker

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Биопрепараты

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Global API & Biosimilars QC Suite LabEx QC Suite

Biologic Aggregate Size Quality Checker Charge Variant CE Quality Checker CE Glycosylation Profiler Protein Concentration UV Quality Checker ELISA Bioassay Quality Checker SPR Binding Affinity Quality Checker Residual Host Cell DNA Quality Checker Residual Host Protein Checker

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Вакцины и препараты крови

Huvac — QC утилиты для вакцин человека Плазменные препараты LabEx QC Suite

Vaccine Potency Assessor Adjuvant Aluminum Assay Checker Adjuvant Adsorption Efficiency Quality Checker Inactivated Vaccine Safety Test Quality Checker Live Attenuated Vaccine Genetic Stability Quality Checker Plasma Pool Traceability Checker Plasma Viral Clearance Evidence Checker Cold Chain Shipping Temperature And MKT Quality Checker

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Ветеринарные препараты

Vet — ветеринарные QC утилиты Global API & Biosimilars QC Suite

Herd Flock Vaccine Batch Review Utility Autogenous Vaccine Batch Traceability Utility Antibiotic Potency Assay Checker Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Microbial Enumeration (TAMC/TYMC) Quality Checker

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Витамины и нутрицевтические ингредиенты

Global API & Biosimilars QC Suite

Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Elemental Impurities ICP Quality Checker UV-Vis Identity & Assay Quality Checker AAS Microelements Supplements Stability Condition Monitoring Quality Checker

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Гепарин и плазменные продукты

Плазменные препараты

Heparin Sodium Quality Checker HeparinSodiumMolecularWeightChecker Plasma Pool Traceability Checker Plasma Viral Clearance Evidence Checker Residual Solvent Detergent Checker Bacterial Endotoxins LAL Quality Checker Sterility Test Membrane Filtration Quality Checker

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Гормоны и high-potency API

Global API & Biosimilars QC Suite Эндокринология

Chiral Purity HPLC Quality Checker Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Elemental Impurities ICP Quality Checker Content Uniformity Quality Checker Change Control Impact Checker Process Validation Checker

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Ингаляционные препараты

Ингаляционные продукты Medical Devices / стандарты и lifecycle QC

Delivered Dose Uniformity Inhaler Quality Checker Inhalation APSD Quality Checker Inhaler APSD NGI Profiler Inhaler DDU Uniformity Analyzer Inhaler Leak Test Checker Inhaler Device Lifecycle Tracker Inhaler Stability Performance Checker Requirement Traceability Checker

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Клеточные и генные технологии

Клеточная и генная терапия / вирусные векторы

Vector Genome Titer q PCR Analyzer Replication Competent Virus RCV Quality Checker Residual Host Cell DNA Quality Checker Residual Host Protein Checker Sterility Test Membrane Filtration Quality Checker Bacterial Endotoxins LAL Quality Checker

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Медицинские изделия

Medical Devices / стандарты и lifecycle QC Medical Device Risk Management Medical Device Software Electrical Safety & EMC UDI & Labeling

Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Software Safety Class Checker Data Integrity Security Checker Cybersecurity Risk Assessment Checker Electrical Safety Test Summary Checker

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Международная фармгруппа в Китае

Global API & Biosimilars QC Suite Medical Device QMS Medical Device Software

Change Control Impact Checker Process Validation Checker Method Validation Data Packager Data Integrity Security Checker Requirement Traceability Checker Supplier Evaluation Checker Production Record Consistency Checker Release Readiness Checker

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Онкология, ADC и high-potency

ADC / конъюгированные биопрепараты Global API & Biosimilars QC Suite

ADC Aggregation Monitor ADC Drug Antibody Ratio Analyzer ADC Free Payload Quantifier ADC Linker Stability Profiler ADCRelease Readiness Checker Assay & Impurity HPLC Quality Checker LC-MS Confirmation Quality Checker Sterility Test Membrane Filtration Quality Checker

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Офтальмологические препараты

Офтальмологические и интравитреальные продукты LabEx QC Suite

Ophthalmic Solution Quality Checker Ophthalmic Osmolality PHChecker Ophthalmic Particulate Matter Checker Ophthalmic Container Closure Integrity Checker Ophthalmic Extractables Leachables Checker Ophthalmic Sterility Endotoxin Ultra Checker

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Пептиды и инсулины

Пептиды, GLP‑1 и препараты ожирения

CE Peptide Map Validator CE Peptide Map Fingerprint LC-MS Confirmation Quality Checker Insulin Analog Impurity Checker InsulinHumanHPLCChecker Human Insulin Quality Checker GLP1 Injectable Release Checker Bacterial Endotoxins LAL Quality Checker

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Радиофармацевтика

RPH: объединённый радиофармацевтический QC-пакет Радиолигандная терапия и тераностика

Radionuclidic Purity Checker Bacterial Endotoxins LAL Quality Checker Sterility Test Membrane Filtration Quality Checker Particle Count Injection USP <788> Quality Checker Cold Chain Shipping Temperature And MKT Quality Checker

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Стерильные препараты

LabEx QC Suite Sterile Medical Devices Китай: пакет утилит по национальному списку основных лекарств

Sterility Test Membrane Filtration Quality Checker Bacterial Endotoxins LAL Quality Checker Particle Count Injection USP <788> Quality Checker Filter Integrity Test Quality Checker Package Integrity & Leak Test Quality Checker Water For Injections Quality Checker Osmolality Quality Checker Fill Volume & Container Closure Checker

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Трансдермальные системы

Global API & Biosimilars QC Suite Medical Devices / стандарты и lifecycle QC

Assay & Impurity HPLC Quality Checker Content Uniformity Quality Checker Residual Solvents GC Quality Checker Stability Condition Monitoring Quality Checker Packaging Integrity Checker Supplier Evaluation Checker

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Фармацевтическое оборудование и engineering

Medical Devices / стандарты и lifecycle QC Medical Device Software Medical Device QMS

Design Control Compliance Checker Supplier Evaluation Checker Calibration Schedule Checker Calibration Status Checker Process Validation Checker Requirement Traceability Checker Configuration Baseline Checker Integration Test Coverage Checker

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Химические препараты и готовые формы

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Китай: пакет утилит по национальному списку основных лекарств Global API & Biosimilars QC Suite Lumex QC Suite LabEx QC Suite

Assay & Impurities Result Reviewer Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Elemental Impurities ICP Quality Checker Content Uniformity Quality Checker Dissolution Apparatus 1 & 2 Quality Checker Stability Condition Monitoring Quality Checker

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