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Traditional Chinese Medicine QC Utility Map

QC utility package for TCM: botanical identity, fingerprint consistency, marker compounds, decoction pieces, Paozhi processing, pesticides, mycotoxins, heavy metals, sulfur fumigation, microbial limits and adulteration screening.

Traditional Chinese Medicine QC Utility Map

QC utility package for TCM: botanical identity, fingerprint consistency, marker compounds, decoction pieces, Paozhi processing, pesticides, mycotoxins, heavy metals, sulfur fumigation, microbial limits and adulteration screening.

Utilities
18
Workflow
CSV → JSON
Decision model
Deterministic QC

The package groups existing FUZKK utilities into a practical QC fit map. It does not replace manufacturer specifications, but shows which checks can be formalized as repeatable CSV→JSON workflows.

RavulizumabQualityChecker is not included in the TCM package: it is a biopharmaceutical mAb utility for a complement C5 inhibitor.

Package utility scope

#UtilityWhy included
1Tcm Adulteration And Filler Detection Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
2Tcm Aristolochic Acids And P As Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
3Tcm Decoction Piece Dimensional Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
4Tcm Dna Barcoding Authenticity Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
5Tcm Endogenous Toxin Transformation Ratio CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
6Tcm Endotoxin And Sterility Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
7Tcm Fingerprint Consistency Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
8Tcm Forbidden Substance Adulteration ScreeningDeterministic CSV→JSON QC utility mapped to this package scope.
9Tcm Fumigants And Solvents Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
10Tcm Heavy Metals And Elements Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
11Tcm Marker Compounds Quantification Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
12Tcm Microbial Limits And Pathogens Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
13Tcm Mycotoxins Profile Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
14Tcm Paozhi Processing Compliance CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
15Tcm Pesticide Multi Residue Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
16Tcm Radionuclides Control Quality CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
17Tcm Species Authentication DNA CheckerDeterministic CSV→JSON QC utility mapped to this package scope.
18Tcm Sulfur Fumigation Excess CheckerDeterministic CSV→JSON QC utility mapped to this package scope.

Why choose FUZKK Utilities?

✅ Replace Excel

No hidden formulas or accidental edits. Deterministic logic, version control and reproducible results.

🔍 Audit-ready (IQ/OQ)

Each utility is supplied with URS & FS templates. This accelerates validation preparation and inspections.

⏱ Save QC time

Automate checks, calculations and reporting. The team focuses on deviations and scientific assessment rather than formatting.

🚀 Fast deployment

CSV input and JSON output allow integration without building heavy custom LIMS modules from scratch.

Integration workflow

LIMS / ELN / CSV export → FUZKK utility → output.json → QMS / eDMS / batch release

The utilities read CSV input and generate structured JSON output suitable for automated batch release, QA/QC review and LIMS/ELN/MES integration.

Utilities and checked parameters

#API / productUtilityKey checks
1Tcm Adulteration And Filler Detectiontcm adulteration and filler detectionTCM Adulteration & Filler Detection Quality Checker — Detection of Adulteration and Fillers in TCM Performs chemometric and analytical authenticity control per USP , EP 2.
2Tcm Aristolochic Acids And P Astcm aristolochic acids and p asTCM Aristolochic Acids & PAs Quality Checker — Screening for Nephrotoxic and Hepatotoxic Toxins in TCM Performs safety control per EMA/HMPC/566819/2014, FDA Import Alert #54-10, ChP 2341 and ICH M7: aristolochic acids (z…
3Tcm Decoction Piece Dimensionaltcm decoction piece dimensionalTCM Decoction Piece Dimensional Quality Checker — Control of Yinpian Dimensional Characteristics in TCM ℹ️ Utility checks physical cutting parameters of herbal raw materials according to ChP 2020 (Chapter 0213) and tradi…
4Tcm Dna Barcoding Authenticitytcm dna barcoding authenticityTCM DNA Barcoding Authenticity Quality Checker — Molecular Verification of TCM Raw Material Authenticity Performs DNA-based species identification per ChP General Chapter 9107, USP , WHO Guidelines on Quality Control of…
5Tcm Endogenous Toxin Transformation Ratiotcm endogenous toxin transformation ratio checkerTCM Endogenous Toxin Transformation Ratio Checker — Control of Endogenous Toxin Transformation Ratios in TCM ℹ️ Utility evaluates safety of toxic medicinal plants through chemometric ratios of transformation products (Pa…
6Tcm Endotoxin And Sterilitytcm endotoxin and sterilityTCM Endotoxin and Sterility Quality Checker — Control of Endotoxins and Sterility in TCM Injectable Preparations ℹ️ Utility performs comprehensive safety assessment of parenteral TCM forms according to ChP 2020 (Chapters…
7Tcm Fingerprint Consistencytcm fingerprint consistencyTCM Fingerprint Consistency Quality Checker — Traditional Chinese Medicine Fingerprint Consistency Control ℹ️ Utility checks chromatographic fingerprint consistency of Traditional Chinese Medicine (TCM): • Similarity ind…
8Tcm Forbidden Substance Adulteration Screeningtcm forbidden substance adulteration screeningTCM Forbidden Substance Adulteration Screening — Screening for Forbidden Synthetic Substances in TCM ℹ️ Utility performs targeted high-sensitivity screening for undeclared pharmaceutical substances in herbal products: •…
9Tcm Fumigants And Solventstcm fumigants and solventsTCM Fumigants and Solvents Quality Checker — Control of Residual Fumigants and Solvents in TCM ℹ️ Utility checks residual amounts of fumigants and solvents according to ChP 2020 and ICH Q3C: • Ethylene oxide (≤1.
10Tcm Heavy Metals And Elementstcm heavy metals and elementsTCM Heavy Metals and Elements Quality Checker — Control of Heavy Metals and Elements in TCM ℹ️ Utility checks content of heavy metals and elements according to ChP 2020: • Lead (Pb) ≤ 5.
11Tcm Marker Compounds Quantificationtcm marker compounds quantificationTCM Marker Compounds Quantification Quality Checker — Quantitative Determination of TCM Marker Compounds ℹ️ Utility checks results of quantitative analysis of marker compounds according to ChP 2020 and ICH Q2(R1): • Acti…
12Tcm Microbial Limits And Pathogenstcm microbial limits and pathogensTCM Microbial Limits and Pathogens Quality Checker — Control of Microbial Limits and Pathogens in TCM ℹ️ Utility checks microbiological purity of Traditional Chinese Medicine according to ChP 2020 and WHO guidelines: • T…
13Tcm Mycotoxins Profiletcm mycotoxins profileTCM Mycotoxins Profile Quality Checker — Control of Mycotoxin Profile in TCM ℹ️ Utility checks content of major mycotoxins according to ChP 2020 (Chapter 2351) and EU regulations: • Aflatoxin B1: ≤5 ppb (μg/kg) • Aflatox…
14Tcm Paozhi Processing Compliancetcm paozhi processing compliance checkerTCM Paozhi Processing Compliance Checker — Control of Paozhi Processing Compliance in TCM ℹ️ Utility verifies compliance with traditional herbal processing methods: • Chemical transformation coefficient (product/substrat…
15Tcm Pesticide Multi Residuetcm pesticide multi residueTCM Pesticide Multi-Residue Quality Checker — Pesticide Multi-Residue Analysis in TCM ℹ️ Utility checks content of key pesticide classes according to ChP 2020 (Chapter 2341) and EU regulations: • Organochlorines: BHC Tot…
16Tcm Radionuclides Controltcm radionuclides controlTCM Radionuclides Control Quality Checker — Control of Radionuclides in TCM ℹ️ Utility checks content of technogenic and natural radionuclides according to ChP 2020 (Chapter 2361), WHO and IAEA standards: • Cesium-137 (C…
17Tcm Species Authentication DNAtcm species authentication dna checkerTCM Species Authentication DNA Checker — Molecular Species Authentication of TCM (DNA Barcoding) ℹ️ Utility performs species identification of medicinal plant and animal raw materials by DNA barcoding according to ChP 20…
18Tcm Sulfur Fumigation Excesstcm sulfur fumigation excess checkerTCM Sulfur Fumigation Excess Checker — Control of Excessive Sulfur Fumigation in TCM ℹ️ Utility performs comprehensive assessment of sulfur dioxide fumigation consequences according to ChP 2020 (Chapter 2331): • Total su…

Package positioning

The package is a marketing and technical selection. It is suitable for the first discussion with QC, portfolio coverage assessment, pilot scoping and integration planning.

TCM TraditionalChineseMedicine ChinesePharmacopoeia Herbal BHP BotanicalQC CSV→JSON

Licensing & support

  • License is granted to one pharmaceutical company or manufacturing site, with no redistribution rights.
  • Utilities are provided as is; validation is performed by the client using URS & FS / IQ/OQ templates.
  • Integration support is available for LIMS/ELN/MES, pilot preparation and CSV/JSON workflow clarification.
  • No public price is shown: the commercial proposal depends on package scope, number of sites, delivery model and support level.

Questions? Need a QC demo or pilot?

Representative — FUZKK Pharma Utilities

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