Thiamine Hydrochloride Powder (Vitamin B1)
Thiamine hydrochloride powder for vitamin B1 supplements, B-complex formulas, nutritional premixes and food fortification, supported by batch-specific quality documentation.
Malzeme Tanımlaması
Vitamin B1 Powder in the Hydrochloride Form
Thiamine hydrochloride is a widely used form of vitamin B1 for nutritional formulations. The powder can be incorporated into standalone B1 products as well as formulas that combine vitamin B1 with other nutrients.
Quality Profile
Thiamine Hydrochloride Powder Specifications
The specification covers identity and key quality parameters for thiamine hydrochloride powder, with corresponding analytical methods and results from a representative batch.
| Test Item | Şartname | Yöntem | Batch Result |
|---|---|---|---|
| Description & Identification | |||
| Açıklama | White crystals or crystalline powder | Görsel | Beyaz kristal toz |
| Infrared Absorption | Consistent with the reference IR spectra | USP | Consistent with the reference IR spectra |
| Chloride | White curdy precipitate forms with silver nitrate; insoluble in nitric acid and readily soluble in ammonia | USP | Complies |
| Appearance of Solution | Clear, not more intense than Y7 or GY7 | EP | Clear, not more intense than Y7 |
| General Quality | |||
| pH | 2.7–3.3 | USP | 3.2 |
| Su | NMT 5.0% | USP | 3.0% |
| Sulphates | NMT 0.03% | USP | <0.03% |
| Ateşleme Üzerinde Kalıntı | NMT 0.1% | USP | 0.01% |
| Absorbance of Solution | NMT 0.025 | USP | 0.018 |
| Limit of Nitrate | No brown ring is produced at the junction of the two layers | USP | Complies |
| Related Compounds | NMT 1.0% | USP | 0.05% |
| Related Substances | |||
| Impurity A | NMT 0.15% | EP | Complies |
| Impurity B | NMT 0.3% | EP | Complies |
| Impurity C | NMT 0.15% | EP | Complies |
| Unspecified Impurity | NMT 0.10% | EP | Complies |
| Total Impurities | NMT 0.5% | EP | Complies |
| Kalan Çözücüler | |||
| Methanol | NMT 0.3% | GC, In-house | <0.3% |
| Ethanol | NMT 0.5% | GC, In-house | <0.5% |
| Tahlil | |||
| Assay, Anhydrous Basis | 98.0%–102.0% | USP | 99.5% |
| Ağır Metaller | |||
| Kurşun | ≤0.5 mg/kg | AAS, In-house | <0.5 mg/kg |
| Kadmiyum | ≤0.5 mg/kg | AAS, In-house | <0.5 mg/kg |
| Arsenik | ≤0.5 mg/kg | AAS, In-house | <0.5 mg/kg |
| Cıva | ≤0,1 mg/kg | AAS, In-house | <0.1 mg/kg |
| Microbiological Quality | |||
| Total Aerobic Microbial Count | NMT 100 cfu/g | ChP | <100 cfu/g |
| Total Yeasts and Moulds Count | NMT 10 cfu/g | ChP | <10 cfu/g |
| E. coli | Olumsuz | ChP | Olumsuz |
| Salmonella | Olumsuz | ChP | Olumsuz |
| S. aureus | Olumsuz | ChP | Olumsuz |
A Certificate of Analysis is available for each supplied batch, with the corresponding analytical results for quality review.
Formulation Role
Where Thiamine Hydrochloride Fits
The hydrochloride form works across several common vitamin B1 applications, from single-vitamin supplements to blended nutritional products.
Vitamin B1 Supplements
Suitable for capsules, tablets and other supplement formats where vitamin B1 is a primary part of the formula.
B-Complex & Multivitamin Formulas
Works as the B1 component alongside other B vitamins or within multivitamin formulations containing a wider nutrient profile.
Premixes & Food Fortification
Can be added to nutritional premixes and fortified-food formulas that use thiamine hydrochloride as their source of vitamin B1.
Documentation & Handling
Quality Documentation for Commercial Supply
Commercial supply is supported by compendial standards, batch documentation and defined packaging and storage conditions.
Compendial Standards
Thiamine hydrochloride meets BP, EP, USP and FCC requirements when tested according to the applicable compendial standards, supporting projects that specify these recognized quality standards.
Packaging & Storage
- Paket
- 25 kg per carton
- Depolama
- Preserve in a tight non-metallic container, protected from light.
- After Opening
- Use within a short period once opened.
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