Carnosine Tablets

Shaanxi BLOOM Tech Co., Ltd. is one of the most experienced manufacturers and suppliers of carnosine tablets in China. Welcome to wholesale bulk high quality carnosine tablets for sale here from our factory. Good service and reasonable price are available.

Carnosine Tablets are a premium dietary supplement featuring the naturally occurring dipeptide β-alanyl-L-histidine, a compound with well-documented antioxidant, anti-glycation, and pH-buffering properties. Bloomtechz manufactures pharmaceutical-grade Carnosine Tablets in standardized 250mg and 500mg strengths, produced under strict GMP conditions with full batch traceability and third-party testing for purity, heavy metals, and microbial limits. Our tablets are designed for optimal stability and bioavailability, with enteric-coated options available to minimize degradation by serum carnosinase and maximize systemic delivery. 

Certificate of Analysis
Compound name	Carnosine
Grade	Pharmaceutical grade
CAS No.	305-84-0
Quantity	18g
Packaging standard	PE bag+Al foil bag
Manufacturer	Shaanxi BLOOM TECH Co., Ltd
Lot No.	202601090055
MFG	Jan 9th 2026
EXP	Jan 8th 2029
Structure
Item	Enterprise standard	Analysis result
Appearance	White or almost white powder	Conformed
Water content	≤5.0%	0.88%
Loss on drying	≤1.0%	0.54%
Heavy Metals	Pb≤0.5ppm	N.D.
	As≤0.5ppm	N.D.
	Hg≤0.5ppm	N.D.
	Cd≤0.5ppm	N.D.
Purity (HPLC)	≥99.0%	99.66%
Single impurity	<0.8%	0.63%
Total microbial count	≤750cfu/g	637
E. Coli	≤2MPN/g	N.D.
Salmonella	N.D.	N.D.
Ethanol (by GC)	≤5000ppm	655ppm
Storage	Store in a sealed, dark, and dry place below -20°C

The stability of L-carnosine in solid oral dosage forms is governed by its inherent physicochemical properties as a zwitterionic dipeptide.

The β-alanyl-L-histidine bond is susceptible to hydrolytic cleavage, particularly under conditions of elevated temperature and humidity, yielding the constituent amino acids β-alanine and L-histidine. Additionally, the imidazole ring of the histidine residue is prone to oxidative degradation upon prolonged exposure to atmospheric oxygen and light, potentially generating histamine and other degradation byproducts. These degradation pathways necessitate a comprehensive, multi-layered stability management strategy from raw material handling through finished product shelf life.

Intrinsic Degradation MechanismsL-carnosine exhibits pH-dependent stability in aqueous environments, with maximum stability observed in the slightly acidic to neutral range (pH 5.5–7.0).

Outside this range, acid-catalyzed or base-catalyzed hydrolysis of the peptide bond accelerates significantly. In the solid state, the primary degradation driver is moisture-mediated hydrolysis, wherein adsorbed water molecules facilitate nucleophilic attack on the amide carbonyl carbon. The rate of this reaction follows Arrhenius kinetics, with degradation velocity approximately doubling for every 10°C increase in storage temperature.

The dipeptide is also sensitive to trace metal ions, particularly copper (Cu²⁺) and iron (Fe³⁺), which can catalyze oxidative degradation through Fenton-type reactions generating hydroxyl radicals. This metal-catalyzed oxidation pathway is particularly relevant during manufacturing, where contact with stainless steel equipment surfaces must be carefully controlled.

Raw Material Stability Control

Bloomtechz implements rigorous raw material stability protocols for the L-carnosine API prior to tablet production. The crystalline powder is stored in double-lined polyethylene bags within aluminum foil laminated containers, providing an effective barrier against moisture vapor transmission (WVTR <0.5 g/m²/day) and oxygen permeation. Storage conditions are maintained at 15–25°C with relative humidity controlled below 40% RH in dedicated climate-controlled warehouses.

Each API lot is subjected to periodic retesting per ICH Q1A(R2) guidelines, with identity confirmation by FT-IR spectroscopy and purity verification by HPLC.The acceptance criterion for related substances (sum of all degradation products) is set at ≤1.0% by area normalization,

 

 

well below the ICH Q3A(R2) identification threshold of 0.10% for any individual unknown impurity. Loss on drying is controlled to ≤0.5%, ensuring minimal residual moisture that could initiate hydrolytic degradation during subsequent processing.

Bloomtechz Carnosine Tablets employ a multi-component stabilization approach optimized through systematic excipient compatibility studies conducted per ICH Q1A(R2) Annex guidelines.

Excipient Selection Rationale: Microcrystalline cellulose (MCC) serves as the primary diluent, selected for its low hygroscopicity (equilibrium moisture content <3% at 50% RH) and neutral pH profile. Croscarmellose sodium functions as the superdisintegrant, chosen over starch-based alternatives due to its superior chemical inertness and lack of reducing sugar content that could participate in Maillard reactions with the histidine residue. Colloidal silicon dioxide (Aerosil®) is incorporated at 0.5–1.0% w/w as a glidant and moisture scavenger, adsorbing trace water molecules that may be introduced during processing.Magnesium stearate, the lubricant, is sourced in pharmaceutical grade with controlled heavy metal content (Pb ≤5ppm, Fe ≤20ppm) to minimize metal-catalyzed oxidation risk.

pH Microenvironment Control: The formulation is designed to maintain a tablet microenvironment pH of 6.0–6.5, the region of maximum carnosine stability. This is achieved through careful selection of excipients with compatible pH profiles and, where necessary, the inclusion of minimal buffering agents. The final tablet pH is verified by the slurry method (10% w/v in purified water) as part of in-process quality control.

Moisture Management: All manufacturing operations involving exposed product are conducted in classified cleanrooms with dew point-controlled air handling systems maintaining ≤10°C dew point (approximately <35% RH at 20°C).Granulation processes, if employed, utilize minimal aqueous binder solutions with immediate drying to target moisture content below 2.0% w/w.Final blend moisture is verified by Karl Fischer titration before compression.

The packaging system serves as the primary defense against environmental degradation factors throughout the product's shelf life. Bloomtechz offers three validated packaging configurations, each selected based on barrier performance data and target market requirements.

All packaging configurations undergo extractables and leachables assessment per USP <1663> and <1664> guidelines to ensure no interaction between packaging materials and the carnosine formulation that could compromise product quality or safety.

[1]Hipkiss, A. R. (2009). "Carnosine and its possible roles in nutrition and health." Advances in Food and Nutrition Research, 57, 87–154.

[2]Derave, W., Ozdemir, M. S., Harris, R. C., et al. (2007). "β-Alanine supplementation augments muscle carnosine content and improves high-intensity exercise performance in elite sprinters." Journal of Applied Physiology, 103(5), 1689–1695. 

[3]Boldyrev, A. A., Aldini, G., & Derave, W. (2013). "Physiology and pathophysiology of carnosine." Physiological Reviews, 93(4), 1803–1845. 

[4]Scheuller, M., & Derave, W. (2020). "Oral carnosine supplementation: Bioavailability, metabolism, and functional outcomes." Amino Acids, 52(6-7), 897–912. 

[5]Gariballa, S., & Sinclair, A. J. (2000). "Carnosine: Potential therapeutic applications in age-related diseases." Journal of Nutrition, Health & Aging, 4(4), 231–235. 

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