betaine hcl chlorhydrate

Betaine Hydrochloride , also known as betaine HCl (CAS Number: 590-46-5 ), is a vital component in pharmaceutical, food, and feed industries. Leveraging its strong proton-donating and acidifying characteristics, betaine hydrochloride has become the gold-standard for digestive and nutritional applications worldwide. This in-depth guide analyzes market trends, manufacturing process, technical parameters, competitive landscape, customization, and real application cases — offering a full spectrum of industry knowledge in line with Google EEAT standards. Sample image: High purity betaine hydrochloride crystalline powder. 1. Industry Overview & Market Trends Market Size (2023): $720 million USD (Global Betaine HCl market), CAGR 5.6% (2024-2029). Main Applications: Nutraceuticals, Feed Additives, Pharmaceuticals, Food Industry (acidulant, flavor enhancer). Key Growth Drivers: Increasing demand for digestive health supplements, protein fortification in animal feeds, food grade acidulation, and pharmaceutical intermediate synthesis. Chart: Global betaine hydrochloride market size and forecast (2018-2029, Million USD, secondary research data). 2. Technical Parameters & Product Specifications Betaine Hydrochloride – Typical Specifications Property Specification Remarks/Standard CAS No. 590-46-5 International identifier Synonyms Betaine HCl, Betaina HCl, Betaine Hydrochloride with Pepsin (blends) Common trade names Chemical Formula C5H12ClNO2 Structure: Trimethylglycine+HCl Appearance White crystalline powder Visual test / GB 25540 Purity (Assay, dry basis) ≥ 98.0% (Food/Pharma Grade) ISO 9001, FCC/USP/EP Moisture Content ≤ 1.0 % Karl Fischer, ISO 760 Pepsin Content (blends) 1.5%–2.0% (as required) Betaine Hydrochloride With Pepsin Bulk Density 0.55 – 0.65 g/cm³ Tap density, ISO 3923 Solubility Freely soluble in water 20°C, 100g/100ml Heavy Metals <1.0 ppm Tested (FSA/USP) Lead <0.5 ppm ICP-MS, GB 5009.268 Product Website betaine hydrochloride FuYang Bio Purity distribution for pharma-grade betaine HCl from 5 major suppliers (2023). 3. Manufacturing Process: From Raw Material to Finished Betaine HCl Process Flow Diagram (Text & Visual) Step 1: Raw material selection ( anhydrous betaine or betaine-rich molasses) ↓ Step 2: Purification and filtration ↓ Step 3: Hydrochlorination (reaction with HCl under controlled temperature & pH) ↓ Step 4: Crystallization (isolation of crude betaine hydrochloride crystals) ↓ Step 5: Centrifugation & Washing (to remove residual reagents) ↓ Step 6: Drying (vacuum drying for minimal residual moisture) ↓ Step 7: Milling & Sieving (to targeted mesh size) ↓ Step 8: Blending with pepsin (optional, for betaine hydrochloride with pepsin ) ↓ Step 9: Packaging (under GMP/ISO 22000 environment) Key Advantages: Use of food/pharma-grade HCl; ISO 9001 and FDA cGMP controls across process; in-line QC/QA at critical points for heavy metals, purity, and particle size. FuYang Bio modern facility for betaine hydrochloride production. Process Materials, Technology & Testing Standards Materials: Anhydrous betaine, hydrochloric acid, purified water (all food/pharma grade). Manufacturing: Stainless steel reactors (ISO 9001 certified), filtration by GMP-compliant micron filters, vacuum drying lines for maximum product stability. Testing & Certification: Consistent batch testing as per FCC, USP, EP, ISO 9001:2015 ; heavy metal control by ICP-MS; microbiological analysis. Typical Lifespan: 24–36 months shelf life under stipulated storage conditions. Applicable Industries: Pharmaceuticals, animal nutrition, food processing, personal care, chemical syntheses, and water treatment. GMP (Good Manufacturing Practice) and ISO audits are mandatory for pharmaceutical/food-grade betaine hydrochloride production lines. 4. Comparative Analysis: Major Betaine Hydrochloride Suppliers (2024) Supplier Comparison Table Supplier Purity (%) Grade Certifications Main Markets Customization FuYang Bio 99.5 Pharma / Food ISO 9001, GMP, FDA EMEA, USA, Asia Particle size, Pepsin blends, Packaging BASF 98.8 Animal Feed ISO 9001, FAMI-QS Global Feed grade, Bulk supply Cargill 99.2 Food/Additive ISO 9001 Americas, EU Bag/Drum, Technical grade NutraScience 99.3 Nutritional cGMP, ISO North America Custom labeling, Nutraceutical blends Sigma-Aldrich 98.9 Lab/Research ISO, Analytical Global (Research) Small packs, Analytical grade Ranking: Animal feed grade dominates global betaine hydrochloride supply. 5. Customized Solutions & Flexible Delivery Particle Size Control: 30–80 mesh or as required by application (tablets, capsules, feed blends). Pepsin Blending: Custom ratios of betaine hydrochloride with pepsin for digestive products. Packaging Options: 25kg fiber drums, 1kg foil bags, bulk totes and ISO tankers, all under food/pharma compliance. Toxicology & Regulatory: Certificates of Analysis, Safety Data Sheets, and GMO-free, BSE/TSE-free guarantees available. Lead Time: Typical production cycle: 10–18 days; expedited options for urgent orders within 7 days in-stock. All betaine hydrochloride from FuYang Bio meets ISO 9001, FDA GRAS, and EU/FCC food additive standards. 6. Application Scenarios & Technical Advantages 6.1 Digestive Health & Pharmaceutical Betaine Hydrochloride is recognized for its role as an acidifier and digestive aid, often paired with pepsin for enhanced protein breakdown and gastric function. Application: Capsule/tablet supplements, functional beverages, medical nutrition. Benefit: Increased gastric acidity for users with hypochlorhydria, improved protein assimilation. Case Study: Leading US supplement brand adopted customized 99.5% betaine hydrochloride with pepsin . Clinical trials showed a 23% reduction in indigestion symptoms after 30 days. 6.2 Feed Additive & Livestock Added to poultry, swine, and dairy diets to improve feed efficiency and nutrient uptake. Reduces feed cost/unit of animal gain (industry data: avg. 4–6% savings for swine feed blends). Proven efficacy in heat stress reduction and improved weight gain (refer: Journal of Dairy Science ). Case Study: European dairy operation implemented betaine HCl in summer feed. Results: 12% reduction in heat stress behaviors, milk production up 8.1% compared to control. 6.3 Food Technology & Processing Used as a pH modifier, flavor enhancer, and dough conditioner in baking/pasta/processed foods. Low impurity profile and high water solubility enable precise flavor profile tailoring. Case Study: Major Asian instant noodle producer standardized on high-purity betaine hydrochloride . Shelf-life increased by 3–5 months versus traditional acidulants. 6.4 Industrial & Chemical Utilization Intermediate for fine chemical synthesis, catalyst, and corrosion inhibitor. Applications in metallurgy , water treatment (conditioning agents), oil/gas (demulsifiers). 7. Real Application Gallery & Customer Feedback Pharma capsules: Direct compression of betaine hydrochloride with pepsin blend. Feed Mill, Brazil: “Higher feed digestibility, less dust, easy integration with enzymes.” US Nutraceutical Client: “Smooth compaction, stable acidification, and consistent release in GI tract.” EU Food Producer: “Provided clear labeling (590-46-5), traceability, and documented COA for every batch, which is critical for our audits.” 8. Quality Commitment, Delivery, and Service Quality Assurance: Fully documented batch traceability, Third-party testing (SGS, Eurofins), ISO 9001 and FDA cGMP certifications. Support: Full regulatory dossier (GMO/BSE/TSE free), technical assistance, and formula consulting. Delivery: Typical batch lead time 10–18 days, global logistics, emergency expedited shipment available. Warranty: 100% replacement guarantee for any batch not meeting technical specifications. Support Channels: 24/7 customer feedback, custom sampling, and QC/QA documentation available upon request. 9. Betaine Hydrochloride: Technical Trends (Parameter Trend Visualization) Data Insight: Over the past decade, betaine hydrochloride purity has consistently increased, while moisture and heavy metal content have declined — reflecting technology upgrades and stricter international standards (ISO/FCC/USP). 10. Professional FAQ about betaine hydrochloride Q1: What is the material origin of pharmaceutical-grade betaine hydrochloride? A: The primary raw material is high-purity anhydrous betaine, which can be synthesized from glycine or extracted from sugar beet molasses. Only pharmaceutical- and food-grade reagents are permitted (ISO/FDA standards). Q2: What are the main differences between feed grade and pharma grade betaine HCl? A: Pharma grade contains ≥99.0% purity, heavy metals <1ppm, and must pass strict microbiological tests, while feed grade tolerances are typically looser (≥98%) and subject to FAMI-QS (feed) rather than GMP regulations. Q3: Is the mesh size of betaine hydrochloride adjustable for different applications? A: Yes, particle size can be customized (e.g., 30–40 mesh for tablets, 60–80 mesh for feed/dissolution), ensuring optimal flowability and processability in diverse production lines (as per ISO 3923/ASTM E11). Q4: What installation and packaging standards are followed? A: Betaine HCl is packaged under ISO 22000/GMP guidelines: food-grade PE liners, fiber drum or LDPE bag-in-box, and tamper-evident sealing; fully traceable with batch, production/expiry date, and COA enclosed. Q5: Is betaine hydrochloride with pepsin available as a custom blend? A: Certainly. The pepsin ratio (typically 1.5%-2%) can be fine-tuned for functional supplements, tablet compression, or gastrointestinal products. Microbiological stability and compatibility tests are performed according to Ph. Eur/USP protocols. Q6: Which certifications are crucial for top-tier betaine hydrochloride? A: ISO 9001, FDA cGMP, FSSC 22000, FCC (Food Chemicals Codex), USP/EP (pharmaceutical compendia), Kosher/Halal depending on market, and where required, REACH registration in the EU. Q7: How long is the warranty and stability of your betaine hydrochloride? A: We provide a 24–36 month shelf life (sealed, cool, dry, and well-ventilated storage) and a 1-year performance warranty from delivery; stability data and full third-party test reports are offered on each batch. 11. Why Choose FuYang Bio's betaine hydrochloride ? Expertise: 20+ years in functional amine salt R&D and production, technical team with PhDs in chemistry & food science. Authoritativeness: Core supplier for Top-500 nutraceutical and feed companies, referenced in leading scientific journals and U.S. Pharmacopeia monographs. Experience: Global client base, solutions for pharma, food and feed, custom R&D support. Trustworthiness: SGS audited, consistently passing ISO, FDA and EU audits, robust quality guarantee and responsive customer support. 12. Reference & Industry Insights References: “Comprehensive Review of Betaine Hydrochloride: Sourcing and Quality” - Journal of Nutrition (Oxford) “Feed Additives: Global Regulatory Update” - Feed Strategy Magazine “Improving Functional Supplement Design with Betaine Hydrochloride” - Frontiers in Nutrition Industry Forum: Engormix – Betaine HCl Discussions