Addiction Medicine & Controlled Substances QC Suite: QC Utility Fit Map

Standard article for the Addiction Medicine & Controlled Substances QC Suite package: 39 existing FUZKK utilities grouped by QC workflows.

Addiction Medicine & Controlled Substances QC Suite: QC Utility Fit Map

This package highlights existing FUZKK utilities for addiction medicine and regulated medicinal products: addiction-treatment medicines, controlled APIs, opioids, stimulants, sedatives and related release checks.

Standard article for a new FUZKK portal package. The mapping uses existing utility IDs only; no new utility DTOs are added by this JSON.

Utilities

Coverage groups

Type

Pre-Proposal Fit Map

The package does not claim that every utility is required for every manufacturer. It is a pre-proposal utility fit map: an initial map of existing deterministic FUZKK QC tools that may be relevant for this domain.

Coverage groups

Addiction-treatment productsAlcohol / volatile impurity controlsGeneral analytical releaseOpioids and opioid-related medicinesSedatives, benzodiazepines and CNS controlsStimulants and controlled APIs

Utility list

Group	Utility	Fit
Addiction-treatment products	Acamprosate Calcium Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Opioids and opioid-related medicines	Buprenorphine Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Opioids and opioid-related medicines	Codeine Phosphate Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Opioids and opioid-related medicines	Morphine Hydrochloride Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Opioids and opioid-related medicines	Fentanyl Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Opioids and opioid-related medicines	Tramadol Hydrochloride Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Opioids and opioid-related medicines	Oxycodone Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Opioids and opioid-related medicines	Hydrocodone Acetaminophen Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Opioids and opioid-related medicines	Hydromorphone Hydrochloride Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Opioids and opioid-related medicines	Tapentadol Hydrochloride Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Opioids and opioid-related medicines	Opium Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Stimulants and controlled APIs	Cocaine Hydrochloride Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Stimulants and controlled APIs	Mixed Amphetamine Salts Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Stimulants and controlled APIs	Methylphenidate Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Stimulants and controlled APIs	Lisdexamfetamine Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Sedatives, benzodiazepines and CNS controls	Diazepam Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Sedatives, benzodiazepines and CNS controls	Lorazepam Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Sedatives, benzodiazepines and CNS controls	Temazepam Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Sedatives, benzodiazepines and CNS controls	Alprazolam Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Sedatives, benzodiazepines and CNS controls	Clonazepam Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Sedatives, benzodiazepines and CNS controls	Nitrazepam Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Sedatives, benzodiazepines and CNS controls	Ketamine Hydrochloride Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Sedatives, benzodiazepines and CNS controls	Phenobarbital Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Sedatives, benzodiazepines and CNS controls	Primidone Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Addiction-treatment products	Bupropion Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Alcohol / volatile impurity controls	Ethanol And Methanol Validator	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
General analytical release	Assay & Impurity HPLC Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
General analytical release	LC-MS Confirmation Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Alcohol / volatile impurity controls	Residual Solvents GC Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
Alcohol / volatile impurity controls	GC-MS Screening Volatile Impurities Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
General analytical release	UV-Vis Identity & Assay Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
General analytical release	FTIR Identity Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
General analytical release	Raman Identity Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
General analytical release	Dissolution_Profile_f2_Calculator	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
General analytical release	Dissolution Extended Release Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
General analytical release	Stability Condition Monitoring Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
General analytical release	Water Content KF Quality Checker	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
General analytical release	Genotoxic_Impurity_Screener_M7	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.
General analytical release	Batch Release Json Builder	Existing deterministic QC utility mapped to addiction-medicine, controlled medicinal product, identity, assay, impurity or release workflows.

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 / product	Utility	Key checks
1	Acamprosate Calcium	`acamprosate calcium`	Acamprosate Calcium Quality Checker — Acamprosate calcium quality assessment (BP/Ph.
2	Buprenorphine	`buprenorphine`	Buprenorphine Quality Checker — Buprenorphine quality assessment (BP/Ph.
3	Codeine Phosphate	`codeine phosphate`	Codeine Phosphate Quality Checker — Codeine phosphate quality assessment (Ph.
4	Morphine Hydrochloride	`morphine hydrochloride`	Morphine Hydrochloride Quality Checker — Morphine hydrochloride quality assessment (BP/Ph.
5	Fentanyl	`fentanyl`	Fentanyl Quality Checker — Fentanyl quality assessment (BP/Ph.
6	Tramadol Hydrochloride	`tramadol hydrochloride`	Tramadol Hydrochloride Quality Checker — Tramadol hydrochloride quality assessment (Ph.
7	Oxycodone	`oxycodone`	Oxycodone Quality Checker — Opioid Analgesic (Ph. Eur., USP) ℹ️ The utility checks assay, thebaine/codeine/noroxycodone, toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only…
8	Hydrocodone Acetaminophen	`hydrocodone acetaminophen`	Hydrocodone Acetaminophen Quality Checker — Combo Analgesic (USP) ℹ️ The utility checks content of both APIs, PAP (toxicity), thebaine, uniformity, dissolution.
9	Hydromorphone Hydrochloride	`hydromorphone hydrochloride`	Hydromorphone Hydrochloride Quality Checker — Hydromorphone hydrochloride quality assessment (BP/Ph.
10	Tapentadol Hydrochloride	`tapentadol hydrochloride`	Tapentadol Hydrochloride Quality Checker — Tapentadol hydrochloride quality assessment (Ph.
11	Opium	`opium`	Opium Quality Checker — Quality control of Opium (poppy latex) ⚠️ FOR LICENSED PHARMACEUTICAL USE ONLY ℹ️ The utility checks morphine, codeine, thebaine content, loss on drying, and total ash.
12	Cocaine Hydrochloride	`cocaine hydrochloride`	Cocaine Hydrochloride Quality Checker — Cocaine hydrochloride quality assessment (BP/Ph.
13	Mixed Amphetamine Salts	`mixed amphetamine salts`	Mixed Amphetamine Salts Quality Checker — Psychostimulant (USP) ℹ️ The utility checks assay, D/L ratio (3:1), phenylacetone, dissolution profile.
14	Methylphenidate	`methylphenidate`	Methylphenidate Quality Checker — Psychostimulant (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, impurities, toluene, dissolution profile (ER). ℹ️ Does not use machine learning — rule-based logic only. ⚠…
15	Lisdexamfetamine	`lisdexamfetamine`	Lisdexamfetamine Quality Checker — Prodrug (Ph. Eur., USP) ℹ️ The utility checks assay, dexfenfluramine/lysine (hydrolysis), toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic…
16	Diazepam	`diazepam`	Diazepam Quality Checker — Diazepam quality assessment (BP/Ph.
17	Lorazepam	`lorazepam`	Lorazepam Quality Checker — Lorazepam quality assessment (BP/Ph.
18	Temazepam	`temazepam`	Temazepam Quality Checker — Temazepam quality assessment (Ph.
19	Alprazolam	`alprazolam`	Alprazolam Quality Checker — Alprazolam quality assessment (BP/Ph.
20	Clonazepam	`clonazepam`	Clonazepam Quality Checker — Clonazepam quality assessment (BP/Ph.
21	Nitrazepam	`nitrazepam`	Nitrazepam Quality Checker — Nitrazepam quality assessment (BP/Ph.
22	Ketamine Hydrochloride	`ketamine hydrochloride`	Ketamine Hydrochloride Quality Checker — Ketamine hydrochloride quality assessment (BP/Ph.
23	Phenobarbital	`phenobarbital`	Phenobarbital Quality Checker — Phenobarbital quality assessment (BP/Ph.
24	Primidone	`primidone`	Primidone Quality Checker — Primidone quality assessment (Ph.
25	Bupropion	`bupropion`	Bupropion Quality Checker — Antidepressant (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, impurities, dissolution profile (for SR/XL), residual solvents. ℹ️ Does not use machine learning — rule-based log…
26	Ethanol And Methanol Validator	`ethanol and methanol validator`	Ethanol and Methanol Validator — Проверка содержания спиртов (Ph.
27	Assay & Impurity HPLC	`assay impurity hplcquality checker`	Assay & Impurity HPLC Quality Checker — HPLC Assay and Related Substances Control ℹ️ Utility checks critical parameters of HPLC analysis (USP , Ph.
28	LC-MS Confirmation	`lcmsconfirmation`	LC-MS Confirmation Quality Checker — Structural Confirmation by LC-MS ℹ️ Utility checks critical parameters of substance identification by High Resolution Mass Spectrometry (HRMS): • Mass Error: ≤5.
29	Residual Solvents GC	`residual solvents gcquality checker`	Residual Solvents GC Quality Checker — Residual Solvents Control (GC) ℹ️ Utility checks residual solvent content according to ICH Q3C guidelines: • Class 1 (Avoid): Benzene (≤2 ppm) — carcinogen • Class 2 (Limit): Methan…
30	GC-MS Screening Volatile Impurities	`gcmsscreening volatile impurities`	GC-MS Screening Volatile Impurities Quality Checker — Screening of Volatile Impurities (GC-MS) ℹ️ Utility checks critical parameters of volatile organic compound content: • Total volatile impurities: ≤500 ppm (example sc…
31	UV-Vis Identity & Assay	`uvvis identity assay`	UV-Vis Identity & Assay Quality Checker — Control of Identity and Content (UV Spectroscopy) ℹ️ Utility checks identity and quantitative content of active pharmaceutical ingredients by UV spectroscopy according to Pharmac…
32	FTIR Identity	`ftiridentity`	FTIR Identity Quality Checker — Substance Identification by IR Spectroscopy ℹ️ Utility checks critical parameters of IR spectral identification (Ph.
33	Raman Identity	`raman identity`	Raman Identity Quality Checker — Substance Identification by Raman Spectroscopy ℹ️ Utility checks critical parameters of Raman spectral identification: • Hit Quality Index (HQI / Correlation): ≥0.
34	Dissolution Profile f2 Calculator	`dissolution profile f2 calculator`	Utility description: Dissolution Profile f2 Calculator Dissolution Profile f2 Calculator — Calculation of Dissolution Profile Similarity Factor ℹ️ Utility checks similarity of dissolution profiles of two batches (e.
35	Dissolution Extended Release	`dissolution extended release`	Dissolution Extended Release Quality Checker — Control of ER Product Dissolution ℹ️ Utility checks dissolution profile compliance for modified-release forms: • Early time point: control of "dose dumping" • Middle time po…
36	Stability Condition Monitoring	`stability condition monitoring`	Stability Condition Monitoring Quality Checker — Stability Storage Condition Monitoring ℹ️ Utility checks compliance of climate chamber parameters with ICH Q1A(R2) requirements for stability studies: • Long Term: 25°C ±…
37	Water Content KF	`water content kfquality checker`	Water Content KF Quality Checker — Water Content Control (Karl Fischer Method) ℹ️ Utility checks water content by Karl Fischer titration according to Ph.
38	Genotoxic Impurity Screener M7	`genotoxic impurity screener m7`	Utility description: Genotoxic Impurity Screener M7 Genotoxic Impurity Screener M7 — Control of Genotoxic Impurities (ICH M7) ℹ️ Utility checks critical parameters of mutagenic impurity content: • Nitrosamines: ≤ Specifi…
39	Batch Release Json Builder	`batch release json builder`	Batch Release Json Builder — Certificate of Analysis (CoA) Generator ℹ️ Utility performs automated assembly and validation of data for the Certificate of Analysis according to GMP Annex 16 and 21 CFR Part 211.

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.

AddictionMedicine ControlledSubstances Opioids Benzodiazepines Stimulants AlcoholRelated Dissolution CSV→JSON PackageArticle TherapeuticMapping

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?

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