Hemin chloride is a porphyrin iron complex supplied as a biochemical research reagent; it is not the same article as the FDA-approved prescription drug of the same name. This page separates the two, sets out the regulatory position in the main markets, and gives the specification and documentation to request for hemin chloride powder.
What Hemin Chloride Is, and What It Is Not
Hemin chloride is one chemical entity with one CAS number, but three different products carry that name: a laboratory reagent, a licensed biologic, and a food fortification compound.
Chemical identity and CAS number
Two identifiers settle what the material is: hemin chloride and CAS 16009-13-5. Its systematic name is chloro(protoporphyrinato)iron(III), the chloride-bound ferric form of protoporphyrin IX. The table below pairs the identity data with the specification held for this hemin chloride powder, including the values a buyer should match against a batch certificate.
| Parameter | Value | Source |
| Substance name | Hemin chloride | Huilin specification |
| CAS number | 16009-13-5 | Huilin specification |
| Chemical name | Chloro(protoporphyrinato)iron(III) | Huilin specification |
| Molecular formula | C34H32ClFeN4O4 | Huilin specification |
| Molecular weight | 651.94 g/mol | Huilin specification |
| Appearance | Dark blue to blackish crystalline powder | Huilin specification |
| Assay (HPLC) | 95.0% minimum; 99.0% grade on request | Huilin specification |
| Iron content | 7.96% to 8.31% (calculated) | Huilin specification |
| Loss on drying | 2.0% maximum | Huilin specification |
| Shelf life | 36 months | Huilin specification |
The drug and the reagent are different articles of commerce
A buyer searching this material will find the injectable drug first; the two are not interchangeable. Hemin for injection is a licensed biologic derived from processed red blood cells and supplied as a sterile lyophilised powder with sodium carbonate and sorbitol. The reagent-grade hemin chloride powder, CAS 16009-13-5, is a different article of commerce, with a different source and documentation package; nothing about the drug's approval, warnings or use transfers to it.
Medical Uses: What the Approved Drug Is and Is Not
The medical use associated with this substance belongs to the approved drug rather than the raw material, and the prescribing information states its limits precisely.
The labelled indication
The current US prescribing information records the indication in narrow terms: hemin for injection is indicated for amelioration of recurrent attacks of acute intermittent porphyria temporally related to the menstrual cycle in susceptible women, after initial carbohydrate therapy is known or suspected to be inadequate. Three qualifiers sit inside it: one subtype, one population, and one prior therapy that must first have failed.
Stated limitations of use
The label restricts the drug further. Clinicians are directed to consider carbohydrate loading before administration, with the quantity and duration set out in the prescribing information rather than here. The label also records that attacks may reach irreversible neuronal damage, and that therapy cannot repair damage already done. Known hypersensitivity is a contraindication.
What this page deliberately does not provide
Dosing, reconstitution, infusion technique, monitoring schedules and overdose thresholds are set out in the approved prescribing information and are administered only by, or in consultation with, physicians experienced in managing porphyrias. They are deliberately not reproduced here. A raw-material supplier is not the right channel for them, and this page makes no treatment recommendation.
| Aspect | Hemin for injection | Hemin chloride powder |
| Regulatory status | Licensed biologic; human prescription drug | Raw material; framework set by intended use |
| Source material | Processed red blood cells | Per grade; confirm with the supplier |
| Presentation | Sterile lyophilised powder with sodium carbonate and sorbitol | Dark crystalline powder; 1 kg and 25 kg packs |
| Indication | Narrow porphyria indication, as stated in the label | None; no therapeutic claim made |
| Labelled warnings | Phlebitis, iron and ferritin elevation, anticoagulant effect, renal effects, transmissible agents | Not applicable to the powder |
| Who may use it | Physicians experienced in managing porphyrias | Laboratory and industrial buyers |
Regulatory Position by Market
In every market examined, hemin for injection is regulated as a medicine, while the powder is regulated by whatever framework its intended end use falls under.
United States: a licensed biologic
The approved injection carries a biologics licensing application as its marketing status and is labelled as a human prescription drug. The powder has no equivalent general-purpose monograph; the applicable framework follows intended use, and a finished product carrying a disease or treatment claim falls under the drug rules. US status for a specific grade must therefore be established per project, not inferred from the substance name.
China: the food fortification route
China regulates this substance through the food route rather than the drug route. GB 14880-2012, Annex B, lists it among the permitted iron compound sources for food fortification, and GB 1903.52-2021 is the national food safety standard for the fortifier, specifying production from the blood and blood-cell powder of quarantined, qualified animals. It was also added to the 2023 edition of the health-food raw material catalogue for nutrient supplements. Note the source material: animal blood, not human.
What buyers must confirm before any end-use claim
Three items should be settled before any end-use claim. The first is grade and documentation, because a research-grade specification does not support a food or drug use. The second is the jurisdictional route for the intended end use. The third is the source of the material, because the animal-derived food-grade route and the human-blood-derived biologic are not interchangeable in regulatory or quality terms.
| Market | Position | Source |
| United States | Injection is a licensed biologic; the powder follows its intended use | DailyMed prescribing information |
| China | Listed among permitted iron sources for food fortification; national fortifier standard applies | GB 14880-2012 Annex B; GB 1903.52-2021 |
| Other markets | No general-purpose monograph identified in this review | Confirm with the local competent authority |
Laboratory and Research Applications: What Sources Report
Huilin supplies this material as one of its biochemical research reagents, and the evidence for the reagent's uses differs from that for the drug's medical use.
Clinical results reported in the prescribing information
The clinical studies section of the label reports the figures behind the approval. In the initial five open-label studies, 99 patients with acute porphyrias, 72 of them with acute intermittent porphyria, were treated with hemin, and 30 had received prior or concomitant glucose. A clinical response, defined as improvement of symptoms and reduction in pain, occurred in 85.5% of treatment courses, or 141 of 165. Every patient showed a chemical response, defined as normalisation of urinary ALA and PBG.
Heme oxygenase-1 induction and other laboratory uses
Huilin's product documentation lists the reagent's laboratory roles: substrate and inducer in heme oxygenase-1 studies, a peroxidase and catalase mimic in biocatalysis work, and a growth supplement in culture media for fastidious anaerobes. These are research applications of the reagent, sourced to the supplier's own documentation rather than independent trials. They are not therapeutic claims and establish no clinical benefit.
Where the sources do not support a claim
Two claims circulate in supplier content and are unsupported by the documents cited here. The first is that the substance is an effective oral iron supplement for iron deficiency anaemia; no controlled human data supporting that appeared in this review, and the Chinese route is a permitted-source listing rather than an efficacy finding. The second is that it repairs neurological damage, which the prescribing information contradicts.
Specification, Handling and Supply
For a reference material, the constraint that most often decides whether a project is workable is solubility rather than purity.
Solubility and solution preparation
Huilin's specification and safety data sheet record that the powder is practically insoluble in water, soluble in dilute alkali such as 1 M sodium hydroxide, and soluble in DMSO with sonication, and insoluble in dilute acids. The documented laboratory approach is to dissolve it in a small volume of dilute alkali and dilute immediately into a neutral buffer, without letting the alkaline stock stand. Strong oxidising agents are listed as incompatible, and the dry powder is combustible.
Storage, shelf life and packaging
The hemin chloride powder should be held in a well-closed container away from moisture, light and strong oxidising agents; the stated shelf life is 36 months under those conditions. It ships as 1 kg foil bags and 25 kg drums, with a minimum order of 1 kg and samples available for qualification work. Loss on drying is specified at no more than 2.0%.
Batch documentation
A purity figure alone does not support a purchase decision, because the same assay number can sit behind different impurity profiles. The documents worth requesting with every batch of hemin chloride powder are set out below, with what each one establishes.
| Document | What it establishes | Basis |
| Certificate of analysis | Batch-specific assay and impurity results | Huilin specification |
| HPLC chromatogram | Identity and purity profile | Huilin specification |
| Loss on drying | Moisture content against the 2.0% limit | Huilin specification |
| Heavy metals and residual solvents | Limits for the intended route | Per end use |
| Safety data sheet | Handling, incompatibilities, first aid | Huilin specification |
Frequently Asked Questions
Q: What Is Hemin Chloride And What Is Its CAS Number?
A: Hemin chloride is the chloride-bound ferric form of protoporphyrin IX (CAS 16009-13-5), supplied as a biochemical research reagent. Its systematic name is chloro(protoporphyrinato)iron(III). It is not the same article of commerce as the FDA-approved injectable drug, and that drug's approval, warnings and use do not transfer to the powder.
Q: Is Hemin Chloride The Same As Hemin For Injection?
A: No. Hemin for injection is a licensed biologic derived from processed red blood cells and supplied as a sterile lyophilised powder with sodium carbonate and sorbitol. Hemin chloride powder is a separate raw material with its own specification and documentation. The two should never be treated as interchangeable in regulatory or quality terms.
Q: Is Hemin Chloride An Approved Iron Supplement In China?
A: Not in those words. GB 14880-2012, Annex B, lists the compound among permitted iron sources for food fortification, and GB 1903.52-2021 sets the fortifier standard, which specifies production from the blood of quarantined, qualified animals. It also appears in the 2023 health-food raw material catalogue for nutrient supplements. That is a permitted-source route, not an approval of any specific product.
Q: What Clinical Results Support The Medical Use?
A: The prescribing information reports that in the initial five open-label studies, 99 patients with acute porphyrias, 72 of them with acute intermittent porphyria, were treated with hemin; clinical response occurred in 85.5% of treatment courses, or 141 of 165, and every patient showed normalisation of urinary ALA and PBG. Those figures describe the approved drug, not the raw material.
Q: Can Hemin Chloride Powder Be Used As An Oral Iron Supplement?
A: The documents reviewed for this page contain no controlled human data supporting that use, so no efficacy claim can be made here. Whether a specific grade may be used in a food or supplement depends on the grade, its documentation and the market. Buyers should confirm the route with their own regulatory adviser rather than rely on a supplier's application list.
Q: How Should Hemin Chloride Powder Be Stored And Handled?
A: Huilin's specification and safety data sheet direct storage in a well-closed container away from moisture, light and strong oxidising agents, with a stated shelf life of 36 months under those conditions. The powder is combustible and practically insoluble in water, so it is normally dissolved in dilute alkali or in DMSO with sonication. Loss on drying is specified at no more than 2.0%.
For specification sheets, batch documentation or samples of hemin chloride powder, contact our technical team.
Sources
- Recordati Rare Diseases, Inc. PANHEMATIN (hemin for injection) prescribing information. DailyMed, U.S. National Library of Medicine. Label updated 26 February 2026. dailymed.nlm.nih.gov
- National Health Commission of the PRC. GB 14880-2012, National Food Safety Standard for the Use of Nutritional Fortification Substances in Foods, Annex B. nhc.gov.cn
- National Health Commission of the PRC and State Administration for Market Regulation. GB 1903.52-2021, National Food Safety Standard: Food Nutritional Fortifier, Hemin Chloride. Issued 7 September 2021. standard record
- Center for Food Safety and Appraisal, State Administration for Market Regulation. Interpretation of the Health Food Raw Material Catalogue: Nutrient Supplements, 2023 edition. 10 October 2023. cfe-samr.org.cn