SodiumSeleniteQualityChecker

Sodium Selenite

assay heavy metals impurities microbiology minerals premix specification vitamins

Sodium Selenite Quality Checker — Sodium Selenite (Ph. Eur. 2.4.x)

ℹ️ The utility checks assay, selenium content, selenate impurity (critical!), metal impurities, microbiology, pH of solution.
ℹ️ Does not use machine learning — rule-based logic only.
⚠️ Critical for dietary supplements, parenteral nutrition, veterinary preparations, antioxidant complexes.

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

Input format:
BatchNumber,AssayPercent,SeleniumContent,LossOnDrying,HeavyMetals,Arsenic,Lead,Mercury,Cadmium,Selenate,Iron,Potassium,Calcium,Magnesium,Sulfates,Fluorides,TAMC,TYMC,pH,ClarityNTU,ColorAPHA,EthanolPPM,AcetonePPM

Example:
NASE-2026-001,99.5,45.0,0.3,5,1.5,2,0.5,0.3,0.05,0.0005,0.2,0.03,0.005,0.005,30,500,50,6.5,2,30,800,500

— WHY IS THIS NEEDED?
Sodium selenite is an inorganic selenium compound critical for:
• Dietary supplements as selenium source (antioxidant, thyroid support)
• Parenteral nutrition (trace element for TPN)
• Veterinary preparations (selenium deficiency prevention in animals)
• Antioxidant complexes (in combination with vitamin E)
⚠️ HIGHLY TOXIC at high doses! Narrow therapeutic window. Selenate (SeO₄²⁻) impurity control is critical — selenate is more toxic than selenite and has different pharmacokinetics!
Critical parameters:
• Assay 98.0–102.0% (on dried basis)
• Selenium content 44.0–46.0% (key parameter for dosing!)
• Selenate ≤0.1% (critical impurity — oxidation product, more toxic!)
• Loss on drying ≤0.5%
• Heavy metals ≤10 ppm (as lead)
• Arsenic ≤3 ppm, lead ≤5 ppm, mercury ≤1 ppm, cadmium ≤1 ppm
• Iron ≤0.001%, potassium ≤0.5%, calcium ≤0.05%, magnesium ≤0.01%
• Sulfates ≤0.01%, fluorides ≤50 ppm
• Microbiology: TAMC ≤1000 CFU/g, TYMC ≤100 CFU/g
• pH of 5% solution: 5.0–8.0
• Clarity ≤5 NTU, color ≤50 APHA
⚠️ Sodium selenite oxidizes to selenate in air! Requires storage in airtight packaging under inert atmosphere (nitrogen). Analysis must be performed quickly, avoiding air exposure. Strict control is critical for safety!

input.csv

BatchNumber,AssayPercent,SeleniumContent,LossOnDrying,HeavyMetals,Arsenic,Lead,Mercury,Cadmium,Selenate,Iron,Potassium,Calcium,Magnesium,Sulfates,Fluorides,TAMC,TYMC,pH,ClarityNTU,ColorAPHA,EthanolPPM,AcetonePPM
NASE-2026-001,99.5,45.0,0.3,5,1.5,2,0.5,0.3,0.05,0.0005,0.2,0.03,0.005,0.005,30,500,50,6.5,2,30,800,500

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: SodiumSeleniteQualityCheckerAPI / object: Sodium SeleniteCategory: Vitamins and minerals

1. Scope

The Sodium Selenite Quality Checker utility is used for Sodium Selenite. 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: Vitamins and minerals

Tags: assay, heavy metals, impurities, microbiology, minerals, premix, specification, vitamins

2. Execution modes

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

3. Key controlled areas

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

4. Domain limits and critical parameters

⚠️ Critical for dietary supplements, parenteral nutrition, veterinary preparations, antioxidant complexes.
⚠️ HIGHLY TOXIC at high doses! Narrow therapeutic window. Selenate (SeO₄²⁻) impurity control is critical — selenate is more toxic than selenite and has different pharmacokinetics!
Critical parameters:
Assay 98.0–102.0% (on dried basis)
Selenium content 44.0–46.0% (key parameter for dosing!)
Selenate ≤0.1% (critical impurity — oxidation product, more toxic!)
Loss on drying ≤0.5%
Heavy metals ≤10 ppm (as lead)
Arsenic ≤3 ppm, lead ≤5 ppm, mercury ≤1 ppm, cadmium ≤1 ppm
Iron ≤0.001%, potassium ≤0.5%, calcium ≤0.05%, magnesium ≤0.01%
Sulfates ≤0.01%, fluorides ≤50 ppm
Microbiology: TAMC ≤1000 CFU/g, TYMC ≤100 CFU/g
pH of 5% solution: 5.0–8.0
Clarity ≤5 NTU, color ≤50 APHA
⚠️ Sodium selenite oxidizes to selenate in air! Requires storage in airtight packaging under inert atmosphere (nitrogen). Analysis must be performed quickly, avoiding air exposure. Strict control is critical for safety!

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 Sodium Selenite 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, residual solvents, microbiology and pathogens, 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	`NASE-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	`SeleniumContent`	decimal	as specified	Selenium Content	`45.0`	numeric value; compared with assay/purity limit from specification or method
4	`LossOnDrying`	decimal	as specified	Loss On Drying	`0.3`	mandatory numeric value; rule comparison is performed by the utility
5	`HeavyMetals`	decimal	as specified	Heavy Metals	`5`	numeric value; checked as elemental/metal impurity
6	`Arsenic`	decimal	as specified	Arsenic	`1.5`	numeric value; checked as elemental/metal impurity
7	`Lead`	decimal	as specified	Lead	`2`	numeric value; checked as elemental/metal impurity
8	`Mercury`	decimal	as specified	Mercury	`0.5`	numeric value; checked as elemental/metal impurity
9	`Cadmium`	decimal	as specified	Cadmium	`0.3`	numeric value; checked as elemental/metal impurity
10	`Selenate`	decimal	as specified	Selenate	`0.05`	mandatory numeric value; rule comparison is performed by the utility
11	`Iron`	decimal	as specified	Iron	`0.0005`	mandatory numeric value; rule comparison is performed by the utility
12	`Potassium`	decimal	as specified	Potassium	`0.2`	mandatory numeric value; rule comparison is performed by the utility
13	`Calcium`	decimal	as specified	Calcium	`0.03`	mandatory numeric value; rule comparison is performed by the utility
14	`Magnesium`	decimal	as specified	Magnesium	`0.005`	mandatory numeric value; rule comparison is performed by the utility
15	`Sulfates`	decimal	as specified	Sulfates	`0.005`	mandatory numeric value; rule comparison is performed by the utility
16	`Fluorides`	decimal	as specified	Fluorides	`30`	mandatory numeric value; rule comparison is performed by the utility
17	`TAMC`	decimal	as specified	TAMC	`500`	numeric value; compared with microbiological limits
18	`TYMC`	decimal	as specified	TYMC	`50`	numeric value; compared with microbiological limits
19	`pH`	decimal	pH	p H	`6.5`	mandatory numeric value; rule comparison is performed by the utility
20	`ClarityNTU`	decimal	as specified	Clarity NTU	`2`	mandatory numeric value; rule comparison is performed by the utility
21	`ColorAPHA`	decimal	as specified	Color APHA	`30`	mandatory numeric value; rule comparison is performed by the utility
22	`EthanolPPM`	decimal	ppm	Ethanol PPM	`800`	numeric value; checked as residual solvent against the applicable limit
23	`AcetonePPM`	decimal	ppm	Acetone PPM	`500`	numeric value; checked as residual solvent against the applicable limit

CSV example

BatchNumber,AssayPercent,SeleniumContent,LossOnDrying,HeavyMetals,Arsenic,Lead,Mercury,Cadmium,Selenate,Iron,Potassium,Calcium,Magnesium,Sulfates,Fluorides,TAMC,TYMC,pH,ClarityNTU,ColorAPHA,EthanolPPM,AcetonePPM
NASE-2026-001,99.5,45.0,0.3,5,1.5,2,0.5,0.3,0.05,0.0005,0.2,0.03,0.005,0.005,30,500,50,6.5,2,30,800,500

7. FS — functional specification

ID	Function	Implementation description
FS-001	CLI entry point	The executable `SodiumSeleniteQualityChecker.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 Sodium Selenite, 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": "SodiumSeleniteQualityChecker",
  "api": "Sodium Selenite",
  "batchNumber": "NASE-2026-001",
  "overallStatus": "PASS|WARNING|FAIL",
  "checkedAtUtc": "2026-05-18T00:00:00Z",
  "checks": [
    {
      "parameter": "BatchNumber",
      "value": "NASE-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": "SeleniumContent",
      "value": "45.0",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "LossOnDrying",
      "value": "0.3",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "HeavyMetals",
      "value": "5",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Arsenic",
      "value": "1.5",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Lead",
      "value": "2",
      "unit": "as specified",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "Mercury",
      "value": "0.5",
      "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-005	Positive pathogen/microbiological flag or microbiological limit excursion	Critical FAIL is produced with the offending parameter.
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

Endocrinology QC Suite

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

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Vitamins & Minerals QC Suite

Quality-control package for vitamins, minerals, premixes and nutrient substances.

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