Creatine Monohydrate

As a professional B2B supplier of dietary raw materials, we provide high-purity Creatine Monohydrate tailored for sports nutrition brands, contract manufacturers (CMOs), and global distributors. We understand that commercial procurement requires strict impurity control, particle size precision, consistent batch-to-batch stability, and complete regulatory documentation.

Technical Specifications

Parameter / Test Item	Specification Limit	Test Method
Appearance	White crystalline powder	Visual
Assay (HPLC)	Min. 99.5% (Dry basis)	HPLC / USP Standard
Particle Size Option 1	Standard Grade: 80 Mesh	Sieve Analysis
Particle Size Option 2	Micronized Grade: 200 Mesh	Sieve Analysis
Loss on Drying	Max. 12.0%	USP <731>
Creatinine	Max. 100 ppm	HPLC
Dicyandiamide (DCD)	Max. 20 ppm	HPLC
Dihydrotriazine (DHT)	Negative / Below detection limit	HPLC
Heavy Metals (as Pb)	Max. 10 ppm	ICP-MS / USP <231>
Total Plate Count	Max. 1,000 CFU/g	USP <2021>
Yeast & Mold	Max. 100 CFU/g	USP <2021>
E. coli / Salmonella	Absent in 10g	USP <2022>

Particle Size & Application Matching

Grade	Mesh Size	Characteristics	Recommended Applications
Standard Grade	80 Mesh	Superior bulk density, excellent flowability	Hard capsules, direct-compression tablets
Micronized Grade	200 Mesh	Ultra-fine particle size, rapid suspension, smooth mouthfeel	Ready-to-mix powders, pre-workouts, stick packs, sachets

Quality Control & Safety Assurance

Chemical Residue Control: Strict limit testing for Dicyandiamide (DCD) and Dihydrotriazine (DHT) ensures zero risk of unwanted synthetic by-products.

Heavy Metal Trace Analysis: Advanced ICP-MS testing guarantees compliance with global regulatory standards (including California Proposition 65 and European Union limits).

Batch Traceability: Every drum is assigned a unique batch number mapped directly to raw material origin, production logs, and QA test reports.

Retention Sample Protocol: Samples from every batch are retained for up to 3 years under controlled conditions to support long-term quality monitoring.

Packaging, Storage & Shipping

Standard Unit: 25 kg Fiber Drums or 25 kg Heavy-Duty Kraft Paper Bags with double PE inner moisture-barrier liners.

Palletization: Export-standard pallets (500 kg to 1,000 kg per pallet), fully stretch-wrapped and corner-protected.

Custom Packaging: OEM and custom labeling options available upon request.

Quality & Regulatory Documentation

To support your regulatory clearance and QA approval, the following document dossier is available upon inquiry:
Lot-specific Certificate of Analysis (COA)

Technical Data Sheet (TDS)

Safety Data Sheet (SDS / MSDS)

cGMP / ISO 22000 / FSSC 22000 Certifications

Halal & Kosher Certifications

Non-GMO, Non-Irradiated, Allergen-Free, and Vegan Declarations

Request a Sample or Bulk Quotation

Free R&D Samples: 100g to 500g trial samples dispatched within 48 hours for lab evaluation.

Flexible MOQs: Support for pilot runs through to full container loads (FCL).

Global Shipping: Fast air express for R&D trials or sea freight for commercial orders.

FAQ

Q: What is Creatine Monohydrate used for?

A: Creatine Monohydrate is widely used as a raw material in sports nutrition and dietary supplement products, including powders, capsules, tablets, pre-workout formulas and single-serving sachets.

Q: What should I check when buying bulk Creatine Monohydrate?

A: Buyers should review the assay, impurity limits, particle size, moisture, heavy metals, microbiological specifications, packaging, COA and supplier documentation. MOQ, lead time and repeat supply capability should also be confirmed.

Q: What is the difference between standard and micronized Creatine Monohydrate?

A: The main difference is particle size. Micronized Creatine Monohydrate contains finer particles and may offer different powder-handling and blending characteristics. The appropriate grade depends on the formulation and manufacturing process.

Q: Can I request a COA before placing an order?

A: Yes. A recent or representative COA can be requested during supplier qualification. The final shipment should be supported by a batch-specific COA corresponding to the supplied material.

Q: Which impurities are commonly tested in Creatine Monohydrate?

A: Common quality parameters include dicyandiamide (DCD), dihydrotriazine (DHT), creatinine, heavy metals, moisture and microbiological parameters. The exact limits should be confirmed against the applicable product specification.

Q: Can Creatine Monohydrate be used for capsules and tablets?

A: Yes. Creatine Monohydrate is commonly used in capsule and tablet formulations. Particle size and powder-flow characteristics should be evaluated according to the manufacturer's equipment and formulation.

Q: What documents are normally required for international purchasing?

A: Common documents include COA, TDS, SDS and product specifications. Depending on the buyer's quality system and destination market, additional documents such as allergen, non-GMO, vegan, microbiological or heavy-metal documentation may be requested.

Q: What information should I provide when requesting a quotation?

A: Provide the required specification, particle size, estimated quantity, packaging requirements, application, destination country and documentation requirements.

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