Kre-Alkalyn®
pH-buffered creatine monohydrate
CreatineLast reviewed: July 9, 2026
Medical & Industry Advisor: Dr. James Pendleton, ND
Answer
Availability
We have not verified a current supply status for this ingredient. Unknown is our default: we publish a status only with dated evidence. If you have first-hand sourcing information, use the correction link below.
Owner and access
- Access model
- Licensed program
What it is
- Buffered-creatine brand listed among All American Pharmaceutical's proprietary ingredients; the owner is also a US contract manufacturer. [allamericanpharmaceutical.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. The underlying material is creatine monohydrate, 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, 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; a CoA that names the identity method is the paper trail your own quality file needs. |
| Buffering and pH specification | Kre-Alkalyn® is a pH-buffered creatine monohydrate (US Patent 6,399,661). Ask for the buffering agent, the target pH range, and any specification the owner applies to the buffered material.[allamericanpharmaceutical.com — Kre-Alkalyn patented pH-buffered creatine] | The buffer is what distinguishes this material from plain monohydrate; the buffering agent and pH belong on the spec so your formula and analytical methods account for them. |
| Synthesis-route impurity limits | Request limits and results for dicyandiamide (DCD), dihydrotriazine (DHT), and creatinine on the underlying creatine. 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] | The buffered material is still made from synthetic creatine, so the same manufacturing byproducts and limits apply. |
QC and testing considerations
- Every dietary ingredient must pass at least one validated identity test before use (21 CFR 111.75(a)(1)). Confirm identity testing is run on each incoming lot, not only at supplier qualification. [21 CFR 111.75(a)(1)]
- The buffered material is still made from synthetic creatine and can carry dicyandiamide, dihydrotriazine, and creatinine. Ask for a certificate of analysis that reports these byproducts against the accepted limits. [EFSA Scientific Panel opinion on creatine monohydrate, EFSA Journal 2004;36]
- Creatine converts to creatinine in the presence of water and heat. If a buffered material is positioned for stability in solution, verify that positioning with your own accelerated stability testing on the finished product rather than relying on the raw-material claim. [USP-NF Creatine monograph]
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, EFSA Journal 2004;36 Regulatory
- allamericanpharmaceutical.com — Kre-Alkalyn patented pH-buffered creatine (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
- All American Pharmaceutical & Natural Foods Corporation Owner-listed as of Jul 2026 [source]
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.
Kre-Alkalyn® is a registered trademark of All American Pharmaceutical & Natural Foods Corporation. Inventory Ready is not affiliated with, licensed by, or endorsed by the trademark owner.
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