TestosteroneUndecanoateQualityChecker

Testosterone Undecanoate

assay contraceptives fixed-dose combinations heavy metals hormones impurities injectables residual solvents

Testosterone Undecanoate Quality Checker — Testosterone Undecanoate (Testosterone Ester for Replacement Therapy) (Ph. Eur. 2.8.1)

ℹ️ The utility checks assay, specific rotation, melting point, UV ratio, critical impurities (testosterone — hydrolysis product, 17α-epimer), loss on drying, heavy metals, residual solvents.
ℹ️ Does not use machine learning — rule-based logic only.
⚠️ CRITICAL for testosterone replacement therapy drug production (Nebido, Aveed)! Testosterone impurity (≤0.5%) — hydrolysis product of ester! Moisture control critical for stability!

Usage:
TestosteroneUndecanoateQualityChecker.exe → demo mode (console output)
TestosteroneUndecanoateQualityChecker.exe input.csv output.json → evaluate your data

Input format:
BatchNumber,AssayPercent,SpecificRotation,MeltingPoint,UV240_280Ratio,ImpurityTestosterone,Impurity17AlphaEpimer,TotalImpurities,LossOnDrying,HeavyMetals,ResidualSolvents,EthanolPPM,AcetonePPM,ClarityNTU,ColorAPHA

Example:
TU-2026-001,99.5,27.0,60.0,2.0,0.2,0.1,0.4,0.3,5,1500,800,500,2,30

— WHY IS THIS NEEDED?
Testosterone undecanoate — testosterone ester for male replacement therapy:
• Drugs: Nebido (1000 mg/4 mL), Aveed (FDA-approved)
• Intramuscular injection with prolonged action (up to 10–14 weeks)
• Hydrolyzed in vivo to free testosterone
⚠️ CRITICAL:
• Specific rotation +25.0° to +29.0° — key identification parameter (in chloroform)
• Melting point 58.0–62.0°C — confirms crystalline ester structure
• UV ratio A240/A280: 1.8–2.2 — confirms structure (maximum at 240 nm)
• Testosterone ≤0.5% — HYDROLYSIS PRODUCT! Forms on moisture contact, reduces stability and alters pharmacokinetics
• 17α-Epimer ≤0.5% — STEREOISOMER! Affects activity and safety
• Total impurities ≤1.0% — critical for long-acting preparations
⚠️ Special attention: Testosterone undecanoate is EXTREMELY sensitive to moisture and hydrolysis! Requires storage in airtight, moisture-protected packaging at temperature not exceeding 25°C. Analysis must be performed under humidity-controlled conditions! Testosterone impurity is especially critical — even minor amounts indicate ester degradation and disrupt in vivo release profile. Loss on drying control (≤0.5%) is mandatory to prevent hydrolysis.
Critical parameters:
• Assay: 97.0–103.0% (on dried basis)
• Specific rotation: +25.0° to +29.0° (in chloroform)
• Melting point: 58.0–62.0°C
• UV ratio A240/A280: 1.8–2.2
• Testosterone (hydrolysis): ≤0.5% (HYDROLYSIS PRODUCT!)
• 17α-Epimer: ≤0.5% (STEREOISOMER!)
• Total impurities: ≤1.0%
• Loss on drying: ≤0.5% (moisture control!)
• Heavy metals: ≤10 ppm
• Residual solvents: ≤5000 ppm (total), ethanol ≤5000 ppm, acetone ≤5000 ppm
• Clarity of 0.1% solution in methanol: ≤5 NTU
• Color of 0.1% solution in methanol: ≤50 APHA
⚠️ Note: This utility is for SUBSTANCE (active pharmaceutical ingredient), not finished injectable solutions! Quality control of substance is the first and most important step in production. Only pure substance guarantees ester stability, correct in vivo release profile, and safety of testosterone replacement therapy. Testosterone undecanoate-based drugs require strict quality control due to prolonged action and overdose risk.

input.csv

BatchNumber,AssayPercent,SpecificRotation,MeltingPoint,UV240_280Ratio,ImpurityTestosterone,Impurity17AlphaEpimer,TotalImpurities,LossOnDrying,HeavyMetals,ResidualSolvents,EthanolPPM,AcetonePPM,ClarityNTU,ColorAPHA
TU-2026-001,99.5,27.0,60.0,2.0,0.2,0.1,0.4,0.3,5,1500,800,500,2,30

URS & FS — user requirements and functional specification

This document defines user requirements and functional specification for the quality-control utility. It supports deployment discussion, IQ/OQ preparation and QC workflow integration.

Utility: TestosteroneUndecanoateQualityCheckerAPI / object: Testosterone UndecanoateCategory: Contraceptives

1. Scope

The Testosterone Undecanoate Quality Checker utility is used for Testosterone Undecanoate. The actual input.csv is the source of truth for the input structure; control criteria are defined by the executable and the domain description.

The utility does not use machine learning; decisions are produced by deterministic rules.

Categories: Contraceptives

Tags: assay, contraceptives, fixed-dose combinations, heavy metals, hormones, impurities, injectables, residual solvents

2. Execution modes

TestosteroneUndecanoateQualityChecker.exe                            → demo mode (console output)
TestosteroneUndecanoateQualityChecker.exe input.csv output.json      → evaluate your data

3. Key controlled areas

assay / content
purity and impurities
residual solvents
heavy metals / elemental impurities
pH and physicochemical parameters

4. Domain limits and critical parameters

⚠️ CRITICAL for testosterone replacement therapy drug production (Nebido, Aveed)! Testosterone impurity (≤0.5%) — hydrolysis product of ester! Moisture control critical for stability!
⚠️ CRITICAL:
Specific rotation +25.0° to +29.0° — key identification parameter (in chloroform)
Melting point 58.0–62.0°C — confirms crystalline ester structure
UV ratio A240/A280: 1.8–2.2 — confirms structure (maximum at 240 nm)
Testosterone ≤0.5% — HYDROLYSIS PRODUCT! Forms on moisture contact, reduces stability and alters pharmacokinetics
17α-Epimer ≤0.5% — STEREOISOMER! Affects activity and safety
Total impurities ≤1.0% — critical for long-acting preparations
⚠️ Special attention: Testosterone undecanoate is EXTREMELY sensitive to moisture and hydrolysis! Requires storage in airtight, moisture-protected packaging at temperature not exceeding 25°C. Analysis must be performed under humidity-controlled conditions! Testosterone impurity is especially critical — even minor amounts indicate ester degradation and disrupt in vivo release profile. Loss on drying control (≤0.5%) is mandatory to prevent hydrolysis.
Critical parameters:
Assay: 97.0–103.0% (on dried basis)
Specific rotation: +25.0° to +29.0° (in chloroform)
Melting point: 58.0–62.0°C
UV ratio A240/A280: 1.8–2.2
Testosterone (hydrolysis): ≤0.5% (HYDROLYSIS PRODUCT!)
17α-Epimer: ≤0.5% (STEREOISOMER!)
Total impurities: ≤1.0%
Loss on drying: ≤0.5% (moisture control!)
Heavy metals: ≤10 ppm
Residual solvents: ≤5000 ppm (total), ethanol ≤5000 ppm, acetone ≤5000 ppm
Clarity of 0.1% solution in methanol: ≤5 NTU
Color of 0.1% solution in methanol: ≤50 APHA
⚠️ Note: This utility is for SUBSTANCE (active pharmaceutical ingredient), not finished injectable solutions! Quality control of substance is the first and most important step in production. Only pure substance guarantees ester stability, correct in vivo release profile, and safety of testosterone replacement therapy. Testosterone undecanoate-based drugs require strict quality control due to prolonged action and overdose risk.

Limits stated in the description must be verified against the current approved specification, pharmacopoeial monograph and registration dossier before production use.

5. URS — user requirements

ID	Requirement	Criticality	Acceptance criterion
URS-001	The system shall accept an `input.csv` file for Testosterone Undecanoate with the exact columns listed in the “Input data contract” section.	High	A file with the correct header is processed without manual editing; missing mandatory columns produce FAIL/import error.
URS-002	The system shall support execution without arguments in demo mode and execution with `input.csv output.json` for user data.	Medium	Both execution scenarios produce a predictable result or clear diagnostic error.
URS-003	The system shall perform rule-based controls for: assay / content, purity and impurities, residual solvents, heavy metals / elemental impurities, pH and physicochemical parameters.	High	Each controlled parameter receives a status and message; the result does not depend on hidden Excel formulas or ML.
URS-004	The system shall preserve traceability between batch/lot, source values, applied rules and final verdict.	High	Output includes batch identifier, source values, parameter statuses and critical findings.
URS-005	The system shall generate machine-readable `output.json` for LIMS/ELN/MES, batch record and QA/QC review.	High	JSON contains overall status, check array, warnings, failures and source-file reference.
URS-006	The system shall support use in the client validation package: URS/FS, IQ/OQ preparation, installation and operational scenario checks.	High	The document, test scenarios and reproducible CSV/JSON flow are suitable for audit and internal approval.
URS-007	The system shall clearly separate technical data errors from specification nonconformities.	Medium	Schema/type errors are not mixed with pharmacopoeial deviations and are reported separately.

6. input.csv data contract

The source of truth for the input schema is the actual input.csv header. Column names are technical identifiers and are not translated.

#	Column	Type	Unit	Description	Sample	Control rule
1	`BatchNumber`	identifier	as specified	Batch Number	`TU-2026-001`	mandatory field; used for batch/lot traceability
2	`AssayPercent`	decimal	%	Assay %	`99.5`	numeric value; compared with assay/purity limit from specification or method
3	`SpecificRotation`	decimal	as specified	Specific Rotation	`27.0`	mandatory numeric value; rule comparison is performed by the utility
4	`MeltingPoint`	decimal	°C	Melting Point	`60.0`	mandatory numeric value; rule comparison is performed by the utility
5	`UV240_280Ratio`	decimal	as specified	UV240 280 Ratio	`2.0`	mandatory numeric value; rule comparison is performed by the utility
6	`ImpurityTestosterone`	decimal	as specified	Impurity Testosterone	`0.2`	numeric value; compared with individual or total impurity limit
7	`Impurity17AlphaEpimer`	decimal	as specified	Impurity17 Alpha Epimer	`0.1`	numeric value; compared with individual or total impurity limit
8	`TotalImpurities`	decimal	as specified	Total Impurities	`0.4`	mandatory numeric value; rule comparison is performed by the utility
9	`LossOnDrying`	decimal	as specified	Loss On Drying	`0.3`	mandatory numeric value; rule comparison is performed by the utility
10	`HeavyMetals`	decimal	as specified	Heavy Metals	`5`	numeric value; checked as elemental/metal impurity
11	`ResidualSolvents`	decimal	as specified	Residual Solvents	`1500`	numeric value; checked as residual solvent against the applicable limit
12	`EthanolPPM`	decimal	ppm	Ethanol PPM	`800`	numeric value; checked as residual solvent against the applicable limit
13	`AcetonePPM`	decimal	ppm	Acetone PPM	`500`	numeric value; checked as residual solvent against the applicable limit
14	`ClarityNTU`	decimal	as specified	Clarity NTU	`2`	mandatory numeric value; rule comparison is performed by the utility
15	`ColorAPHA`	decimal	as specified	Color APHA	`30`	mandatory numeric value; rule comparison is performed by the utility

CSV example

BatchNumber,AssayPercent,SpecificRotation,MeltingPoint,UV240_280Ratio,ImpurityTestosterone,Impurity17AlphaEpimer,TotalImpurities,LossOnDrying,HeavyMetals,ResidualSolvents,EthanolPPM,AcetonePPM,ClarityNTU,ColorAPHA
TU-2026-001,99.5,27.0,60.0,2.0,0.2,0.1,0.4,0.3,5,1500,800,500,2,30

7. FS — functional specification

ID	Function	Implementation description
FS-001	CLI entry point	The executable `TestosteroneUndecanoateQualityChecker.exe` supports demo mode and `input.csv output.json` processing mode.
FS-002	CSV parser	The import module reads CSV, validates header, column presence/order, value count and encoding. Decimal values are expected with a dot separator.
FS-003	Field conversion	Each column is converted to the expected type: identifier, text, decimal number, date/time or boolean flag.
FS-004	Domain rule engine	For Testosterone Undecanoate, explicit rules are applied: range, minimum, maximum, absence of prohibited flag, data completeness or calculation-based check.
FS-005	Criticality handling	Critical violations produce FAIL; non-critical deviations and incomplete data produce WARNING; full conformance produces PASS.
FS-006	JSON writer	`output.json` stores overall status, per-parameter results, source values, warnings, failures and diagnostic messages.
FS-007	Integration contract	The CSV → JSON format is stable for invocation from LIMS/ELN/MES, scheduled task or wrapper service.
FS-008	Error handling	Schema error, missing file, non-numeric value or JSON write failure returns diagnosable error without silent PASS.

8. output.json contract

The output file must be suitable for automated processing, audit review and correlation with the source input.csv row.

{
  "utility": "TestosteroneUndecanoateQualityChecker",
  "api": "Testosterone Undecanoate",
  "batchNumber": "TU-2026-001",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "TU-2026-001",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "AssayPercent",
      "value": "99.5",
      "unit": "%",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "SpecificRotation",
      "value": "27.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "MeltingPoint",
      "value": "60.0",
      "unit": "°C",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "UV240_280Ratio",
      "value": "2.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "ImpurityTestosterone",
      "value": "0.2",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Impurity17AlphaEpimer",
      "value": "0.1",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "TotalImpurities",
      "value": "0.4",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": [],
  "sourceFile": "input.csv"
}

9. OQ/PQ test scenarios

ID	Scenario	Expected result
TC-001	Valid CSV with expected header and sample row	All rows are processed; output contains PASS/WARNING/FAIL and parameter-level detail.
TC-002	A mandatory input.csv column is missing	Import is rejected or the row receives FAIL with schema reference.
TC-003	A numeric field contains text or a blank value	Type conversion error is recorded; the result is not hidden as PASS.
TC-004	A parameter is outside specification or critical limit	Critical parameters produce FAIL; non-critical deviations produce WARNING according to the rule.
TC-007	Residual solvent above applicable limit	FAIL is produced with solvent name and measured value.

10. QA/QC, CSV and change control

Before production use, the client records executable version, checksum, specification/monograph version, test CSV, expected JSON and IQ/OQ results.
Column names must not be changed without updating the validator and test scenarios.
The source CSV, output.json and utility version should be stored together as an evidence package.
Any change in control rules must go through change control and repeated OQ scenario verification.

Included in packages

Andrology QC Suite

QC package for andrology: androgens, erectile-dysfunction medicines, BPH/prostate products, fertility and related hormonal checks.

Open

Contraceptives QC Suite

Quality-control package for contraceptives: hormonal APIs, fixed combinations, implants, rings and intrauterine systems.

Open

Endocrinology QC Suite

QC package for endocrinology: thyroid, pituitary/peptide hormones, corticosteroids, sex hormones and selected metabolic medicines.

Open

Gynecology QC Suite

QC package for gynecology: hormones, contraceptives, uterotonics, anti-infectives and women’s-health medicines.

Open