Creapure®
creatine monohydrate
CreatineLast reviewed: July 9, 2026
Medical & Industry Advisor: Dr. James Pendleton, ND
Answer
Availability
Alzchem reports demand outstripping supply ('unable to fulfil all inquiries coming in') and says it must turn down or delay new business while prioritizing long-term customers (trade press, May 2026). Two US contract manufacturers told Inventory Ready in June 2026 they were unable to open new accounts for Creapure runs. Alzchem's new production capacity is expected to begin commissioning in late 2027.
Owner and access
- Owner
- Alzchem Trostberg GmbH (site)
- Access model
- Licensed program
How the owner verifies licensed use
Every licensed Creapure® product carries a seal code verifiable at creapure.com (owner-run, code-by-code lookup; there is no public browsable licensee list). Owner lookup →
What it is
- Produced by Alzchem in Trostberg, Germany; Alzchem describes itself as the only creatine producer outside Asia. [Alzchem investor news]
- Access runs through a trademark license agreement: partnership begins with a direct discussion of requirements; use of the Creapure® logo is permitted only after conclusion of the contract, with terms depending on order quantities and partnership model. [creapure.com]
Spec parameters buyers should demand
What to ask for on the certificate of analysis and spec sheet. Identity, quality, and regulatory parameters only. This is not advice about efficacy.
| Parameter | What to ask | Why it matters |
|---|---|---|
| Assay (creatine content) | Request the certificate of analysis and the assay method. Pharmacopeial creatine is defined as not less than 98.0% and not more than 102.0% creatine on the dried basis (USP-NF); confirm the CoA names the method used.[USP-NF Creatine monograph] | The assay is the identity-and-strength number a spec sheet stands on, and a stated pharmacopeial method makes results comparable across suppliers. |
| Identity verification | Confirm the manufacturer runs at least one validated identity test on each incoming lot (for example infrared or HPLC), as 21 CFR 111.75(a)(1) requires for every dietary ingredient.[21 CFR 111.75(a)(1) — identity test required for each dietary ingredient] | Identity testing is a federal manufacturing requirement, not an optional step; a CoA that names the identity method is the paper trail your own quality file needs. |
| Synthesis-route impurity limits | For synthetic creatine, request limits and results for dicyandiamide (DCD), dihydrotriazine (DHT), and creatinine. The referenced specification is creatinine not more than 100 mg/kg, DCD not more than 50 mg/kg, and DHT not detectable.[EFSA Scientific Panel opinion on creatine monohydrate] | DCD, DHT, and creatinine are byproducts of the sarcosine-plus-cyanamide manufacturing route; these limits are the accepted purity ceiling for the ingredient. |
| Heavy metals | Request lead, arsenic, cadmium, and mercury results with the test method and the limits applied.[USP-NF Creatine monograph] | Heavy-metal control is a baseline quality attribute for any bulk ingredient and part of a complete certificate of analysis. |
| Provenance and licensed-use verification | Request the country and site of manufacture, and for licensed branded material ask how licensed use is verified. Creapure® publishes a seal-code lookup for code-by-code checking.[creapure.com — The Creapure quality seal] | Single-source ingredients concentrate supply risk, and a verifiable provenance plus seal check confirm you are buying the branded material you are paying for. |
QC and testing considerations
- Every dietary ingredient must pass at least one validated identity test before use (21 CFR 111.75(a)(1)). Confirm your manufacturer runs identity testing on each incoming lot, not only at supplier qualification. [21 CFR 111.75(a)(1)]
- Synthetic creatine is made from sarcosine and cyanamide, a route that can leave dicyandiamide, dihydrotriazine, and creatinine behind. Ask for a certificate of analysis that reports these byproducts against the accepted limits, rather than an assay figure alone. [EFSA Scientific Panel opinion on creatine monohydrate, EFSA Journal 2004;36]
- Creatine converts to creatinine in the presence of water and heat, so the anhydrous powder is the stable form. If you are making a liquid or gummy, test the finished product for both creatine content and creatinine, not just the incoming raw material. [EFSA Scientific Panel opinion on creatine monohydrate]
- For sports and team-channel products, ask whether the material carries a banned-substance certification. Creapure® material is listed on the Cologne List; Informed Sport and NSF Certified for Sport are the other common programs. [creapure.com — Quality & Manufacturing]
Further reading: How to read a certificate of analysis and third-party supplement testing.
Reference list
- USP-NF Creatine monograph — identity, assay, and impurity specifications Pharmacopeia
- 21 CFR Part 111 — Current Good Manufacturing Practice for dietary supplements (identity testing at 111.75) Regulatory
- EFSA Scientific Panel opinion on creatine monohydrate for use in foods for particular nutritional uses, EFSA Journal 2004;36 Regulatory
- creapure.com — Quality & Manufacturing (owner technical documentation) Owner technical
A reference list is not claim substantiation. Under the FTC's Health Products Compliance Guidance (December 2022), marketing claims about a finished product require competent and reliable scientific evidence, typically randomized, controlled human clinical testing. Responsibility for substantiating product claims rests with the brand.
Manufacturers with stated capability
No manufacturer has a listed capability for this ingredient yet. Listings are positive-only: an entry states a manufacturer can run the ingredient, never that one cannot.
Run this ingredient? Request inclusion.
Related ingredients in this class
Reference navigation, not a recommendation. Forms and specs differ; evaluate against the criteria on the ingredient reference index.
Further reading
The decision framework behind this reference: five checkable criteria for choosing between a branded ingredient and its generic form.
What this page does not tell you
- Whether the owner will license your specific product or accept a new account.
- Pricing, minimum order volumes, or contract terms.
- Anything about efficacy. This is an identity and sourcing reference.
Prefills the ingredient into the RFQ Spec Builder. You enter your own formula; the tool formats it into a spec sheet.
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