Product Name: Nicotine Ditartrate Dihydrate
Synonym: Nicotine Bitartrate Dihydrate
CAS Number: 6019-06-3
Molecular Formula: CHN2CHO2HO
Molecular Weight: 422.34 g/mol
Therapeutic Category: Nicotine Replacement Therapy (NRT) API
Grade Standard: USP / EP / BP
Nicotine Ditartrate Dihydrate is a highly purified pharmaceutical-grade nicotine salt, widely used in nicotine replacement therapy (NRT) products such as gums, lozenges, patches, and oral sprays. It helps reduce withdrawal symptoms associated with smoking cessation.
|
Parameter |
Specification |
|
Appearance |
White to off-white crystalline powder |
|
Odor |
Slight characteristic odor |
|
Solubility |
Freely soluble in water, slightly soluble in alcohol |
|
pH (1% Solution) |
3.0 4.5 |
|
Melting Point |
~98C 102C |
|
Hygroscopicity |
Hygroscopic |
|
Test Parameter |
Specification |
|
Identification |
Complies with USP / EP / BP |
|
Assay (On Dry Basis) |
98.0% 102.0% |
|
Related Substances |
As per pharmacopeial limits |
|
Water Content |
8.0% 12.0% |
|
Loss on Drying |
NMT 1.0% |
|
Heavy Metals |
As per USP limits |
|
Residual Solvents |
Complies with ICH guidelines |
|
Sulfated Ash |
NMT 0.1% |
|
Microbial Limits |
As per pharmacopeial standards |
Nicotine Replacement Therapy (NRT)
Chewing gums
Lozenges and tablets
Transdermal patches
Oral sprays and inhalers
Standard Packaging: 25 kg Fiber Drum / HDPE Drum with double poly bag
Smaller packs available (1 kg / 5 kg / 10 kg) on request
WHO-GMP Certified Manufacturing
COA (Certificate of Analysis) Available
MSDS Available
Manufactured as per USP / EP / BP standards
High purity pharmaceutical-grade API
Consistent quality and stability
Suitable for global export markets
Reliable bulk supply
Ideal for NRT formulations
Store in a cool, dry place
Protect from light and moisture
Keep container tightly closed
2436 months under recommended storage conditions
Nicotine Ditartrate Dihydrate is a trusted and effective API for modern nicotine replacement therapies. With high purity, compliance with global pharmacopeial standards, and excellent stability, it is widely preferred by pharmaceutical manufacturers worldwide.
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