PrymaLab AnalyticalSafety data sheet · lyophilized powder, vialPrymaLab LLC · 3705 Music Branch Rd, Ashland, KY 41102
Document number
PL-SDS-052
Revision
1.0 · Oct 3, 2026
Erythropoietin (rhEPO) Lyophilized powder, vial · 1 catalogue item
For laboratory research use only. Not for human or veterinary use; not a drug, food, dietary supplement, cosmetic or household product.
1Identification
| Product identifier | Erythropoietin (rhEPO) — lyophilized powder, vial |
|---|---|
| Catalogue items covered | EPO (Erythropoietin) 3000IU PL-EPO-3000IU-VIAL |
| Synonyms / chemical names | Erythropoietin (rhEPO): Recombinant human erythropoietin, epoetin class (CAS 11096-26-7) |
| Recommended use | Laboratory research chemical for in-vitro and animal-model studies by trained personnel. |
| Restrictions on use | Not for human or veterinary use, diagnosis or therapy. Not for use as a drug, food, dietary supplement, cosmetic or in household products. Not for resale to the public for personal use. |
| Supplier | PrymaLab LLC (PrymaLab Analytical), 3705 Music Branch Rd, Ashland, KY 41102, United States · Tel. +1 (606) 465-9063 · michael@prymalab.net · https://prymalab.net |
| Emergency telephone | Poison Help (US, 24 h): 1-800-222-1222 · Supplier (business hours, US Eastern): +1 (606) 465-9063 |
2Hazard(s) identification
Classification of the substance
- Reproductive toxicity, Category 2 — H361
Label elements
GHS08 — Health hazard
Signal word: Warning
Hazard statements
H361Suspected of damaging fertility or the unborn child.
Precautionary statements
Prevention
P201Obtain special instructions before use.P202Do not handle until all safety precautions have been read and understood.P280Wear protective gloves, protective clothing and eye protection.
Response
P308+P313IF exposed or concerned: Get medical advice/attention.
Storage
P405Store locked up.
Disposal
P501Dispose of contents and container to an approved waste disposal plant in accordance with local, state and federal regulations.
Hazards not otherwise classified / other hazards
- Pharmacologically active material. Accidental injection, ingestion or absorption may produce systemic effects consistent with the compound's mechanism of action; see Section 11.
- Finely divided organic powder may form combustible dust concentrations in air if dispersed in bulk (not expected at laboratory scale).
3Composition / information on ingredients
Lyophilized (freeze-dried) powder or cake in a sealed glass vial with a rubber stopper and aluminium crimp cap.
| Ingredient | CAS No. | Formula | Concentration | Quantity | Ingredient classification |
|---|---|---|---|---|---|
| Erythropoietin (rhEPO) Recombinant human erythropoietin, epoetin class | 11096-26-7 | C809H1301N229O240S5 (165-residue protein core) | ≥ 95% (dry basis, as supplied) | 3000 IU per vial | Repr. 2 · H361 |
Peptides are supplied as the acetate or trifluoroacetate salt unless stated otherwise; the counter-ion and residual water make up the balance of a lyophilized product. Concentration limits used for mixture classification follow OSHA HCS 2012 Appendix A.
4First-aid measures
| General | If exposed or concerned, get medical advice. Show this safety data sheet to the doctor. Pregnant or nursing laboratory staff should avoid exposure. |
|---|---|
| Inhalation | Move the person to fresh air and keep comfortable for breathing. If breathing is difficult or symptoms persist, call a POISON CENTER or doctor. |
| Skin contact | Take off contaminated clothing. Wash the skin with plenty of soap and water. If irritation or a rash develops, get medical advice. |
| Eye contact | Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do; continue rinsing. If eye irritation persists, get medical advice. |
| Ingestion | Rinse mouth. Do not induce vomiting. Call a POISON CENTER or doctor if you feel unwell. |
| Most important symptoms and effects | No specific symptoms are known. Pharmacologically active material: systemic effects consistent with its mechanism of action are possible after accidental injection, ingestion or absorption. |
| Indication of immediate medical attention | Treat symptomatically. Show this safety data sheet to the attending physician. No specific antidote is known; monitor for the effects described in Section 11. |
5Fire-fighting measures
| Suitable extinguishing media | Water spray, carbon dioxide, dry chemical or alcohol-resistant foam. Use measures appropriate to the surrounding fire. |
|---|---|
| Unsuitable extinguishing media | None known. Do not use a high-pressure water jet on powders (dust dispersion). |
| Specific hazards | Combustible organic solid; finely divided powder may form dust clouds. Not flammable in the quantities supplied. Thermal decomposition may release carbon monoxide, carbon dioxide and nitrogen oxides, and sulfur oxides. |
| Protective equipment for fire-fighters | Self-contained breathing apparatus and full protective clothing. Prevent run-off from entering drains. |
6Accidental release measures
| Personal precautions | Wear the protective equipment in Section 8. Keep unprotected people away. Avoid dust formation and inhalation of dust. |
|---|---|
| Environmental precautions | Do not allow material to reach drains, surface water or soil. Quantities supplied are small; collect for disposal. |
| Methods for cleaning up | Avoid dust formation. Dampen spilled powder with water, wipe up with absorbent material, place in a sealed container for disposal and clean the area with water and detergent. Decontaminate surfaces with 70% alcohol or detergent and water. |
7Handling and storage
| Precautions for safe handling | Open vials only in a clean area. Avoid generating or inhaling dust; weigh or reconstitute inside a ventilated enclosure when the full contents are handled as a dry powder. Reconstitute by adding diluent slowly to the vial wall; do not shake. Wash hands after handling. Do not eat, drink or smoke in the handling area. Follow the precautionary statements in Section 2. |
|---|---|
| Conditions for safe storage | Store the sealed vial at the temperature stated in Section 9 (typically −20 °C for peptides, 2–8 °C for proteins), desiccated and protected from light. Allow the vial to reach room temperature before opening to avoid condensation. Reconstituted solutions: 2–8 °C, protected from light; use within the period established by your laboratory. Keep the container tightly closed and labelled, out of reach of unauthorised persons (store locked up). |
| Storage temperature | 2–8 °C (sealed vial); −20 °C for long-term storage; protected from light and moisture |
| Incompatible materials | Strong oxidising agents, strong acids and bases. |
8Exposure controls / personal protection
| Occupational exposure limits | No occupational exposure limits (OSHA PEL, ACGIH TLV, NIOSH REL) have been established for any ingredient. |
|---|---|
| Engineering controls | Good general laboratory ventilation. Weigh or manipulate dry powder in a ventilated enclosure (powder hood, biosafety cabinet or fume hood). An eyewash station should be available. |
| Eye / face protection | Safety glasses with side shields (ANSI Z87.1 / EN 166). |
| Skin protection | Nitrile gloves (inspect before use; change after contamination) and a laboratory coat. |
| Respiratory protection | Not normally required with the engineering controls above. Where dust cannot be controlled, use a NIOSH-approved N95 (or P2) particulate respirator. |
| Hygiene measures | Wash hands after handling and before breaks. Remove contaminated clothing. Do not pipette by mouth. |
9Physical and chemical properties
| Physical state / appearance | Solid. White lyophilized powder or cake. |
|---|---|
| Odour / odour threshold | No information available |
| pH | Not applicable (solid); aqueous solutions typically pH 4–7 |
| Melting / freezing point | No information available (protein; denatures on heating) |
| Boiling point | Not applicable (Procrit solution: 100 °C as aqueous) |
| Flash point / flammability | Not applicable (non-flammable solid); combustible organic material |
| Vapour pressure / density | Negligible (solid) |
| Relative density | No data available (bulk density of lyophilized cake is low) |
| Solubility | Soluble in water/PBS; reconstitute lyophilized protein in sterile water at 0.1-1 mg/mL (Invitrogen) |
| Partition coefficient (log Pow) | Not applicable |
| Auto-ignition / decomposition temperature | No data available; peptides decompose above about 200 °C |
| Molecular formula / mass | Erythropoietin (rhEPO): C809H1301N229O240S5 (165-residue protein core), About 30.4 kDa glycoform average; 18.2 kDa protein core |
| Other information | Glycoprotein, 165 amino acids, ~30.4 kDa glycosylated (18.2-18.4 kDa protein core); 3 N- and 1 O-glycosylation sites; expressed in CHO or HEK293 cells. |
10Stability and reactivity
| Reactivity | No hazardous reactivity under normal laboratory conditions. |
|---|---|
| Chemical stability | Stable when stored as recommended (Section 7). Lyophilized peptides are hygroscopic and degrade faster once moist or reconstituted. |
| Possibility of hazardous reactions | None known. |
| Conditions to avoid | Heat, direct light, moisture, repeated freeze–thaw cycles. |
| Incompatible materials | Strong oxidising agents, strong acids and bases; No information available; proteases; denaturants. |
| Hazardous decomposition products | Carbon oxides and nitrogen oxides, sulfur oxides on combustion. No hazardous decomposition under recommended storage. |
11Toxicological information
Likely routes of exposure: Inhalation of dust, skin and eye contact when the vial is opened or the powder is weighed; ingestion through contaminated hands; accidental injection when reconstituted solutions are drawn into syringes.
Symptoms related to the physical, chemical and toxicological characteristics: No specific symptoms are known. Pharmacologically active material: systemic effects consistent with its mechanism of action are possible after accidental injection, ingestion or absorption.
Erythropoietin (rhEPO) Recombinant human erythropoietin, epoetin class · CAS 11096-26-7
Substance classification adopted: Repr. 2 · H361
Janssen (Procrit) SDS: Repr. 2 (embryo-fetal toxicity in animals). Amgen SDSs: not classified. The more conservative classification is adopted.
| Acute toxicity, oral | No information available (Amgen); no adverse effect in acute animal toxicity tests at >20,000 IU/kg (J&J Procrit); no LD50 values |
|---|---|
| Acute toxicity, dermal | No data available |
| Acute toxicity, inhalation | No data available |
| Skin corrosion/irritation | Does not meet GHS classification criteria (Amgen) |
| Serious eye damage/irritation | Does not meet GHS classification criteria (Amgen) |
| Respiratory or skin sensitisation | No data available (J&J); Amgen: does not meet criteria. Recombinant protein powders are potential respiratory sensitisers - see notes |
| Germ cell mutagenicity | Not genotoxic based on a battery of in vitro and in vivo studies (Amgen) |
| Carcinogenicity | Not listed by IARC, NTP or OSHA (J&J); not classified (Amgen). Clinical remark: ESAs carry boxed warnings for tumour progression/shortened survival in some cancer patients |
| Reproductive toxicity | J&J Procrit: 'Potential embryo-foetal toxicity and teratogenicity'; adverse fertility effects in rodents - basis for H361. Amgen: does not meet classification criteria |
| STOT, single exposure | No data available |
| STOT, repeated exposure | J&J target organs: blood, central nervous system, cardiovascular system, immune system (pharmacological: polycythaemia, hypertension, thrombosis, pure red cell aplasia via anti-EPO antibodies) - not classified as STOT RE |
| Aspiration hazard | Not applicable |
- Lyophilised recombinant or purified protein. Inhalation of protein dusts can sensitise susceptible individuals; avoid generating dust and handle the dry powder in a ventilated enclosure. Not classified for respiratory sensitisation because no substance-specific data exist.
- WADA Prohibited List class S2.
Carcinogen listings: no ingredient is listed as a carcinogen by IARC, NTP or OSHA.
12Ecological information
Erythropoietin (rhEPO): No information available for toxicity, persistence, bioaccumulation or mobility (Amgen, J&J). Protein - expected to be biodegradable and of low aquatic toxicity.
Persistence and degradability: peptides and amino acids are expected to biodegrade readily; benzyl alcohol is readily biodegradable (92–96% in 14 days, OECD 301C). Bioaccumulative potential: low (hydrophilic, log Pow < 3 where known). Mobility in soil: water-soluble; mobile. PBT/vPvB: not expected to meet the criteria. Other adverse effects: none known. Do not release concentrated material to the environment.
13Disposal considerations
Dispose of unused material and contaminated packaging through a licensed chemical-waste contractor in accordance with federal (40 CFR 261), state and local regulations; the material is not a listed RCRA hazardous waste but is classified as hazardous for supply and should be managed as chemical waste. Do not pour down the drain. Small residues may be inactivated with 10% bleach for 30 minutes before disposal where local rules allow. Empty glass vials and cartridges: remove labels or deface them before recycling or disposal.
14Transport information
| DOT (49 CFR) / IATA / IMDG | Not regulated as a dangerous good for transport by road (DOT 49 CFR), air (IATA/ICAO) or sea (IMDG). Not a marine pollutant. Ship refrigerated or frozen as required by Section 7; the coolant (dry ice, UN 1845) is regulated when used. |
|---|---|
| UN number / proper shipping name / class / packing group | Not applicable. |
15Regulatory information
| OSHA Hazard Communication Standard (29 CFR 1910.1200) | Hazardous: Reproductive toxicity (Category 2). |
|---|---|
| TSCA (Toxic Substances Control Act) | Erythropoietin (rhEPO): not listed on the TSCA Inventory (supplied for research and development; 40 CFR 720.36). |
| SARA Title III (Sections 302, 311/312, 313), CERCLA | No ingredient is listed as an extremely hazardous substance (Section 302), a Section 313 toxic chemical or a CERCLA hazardous substance. Section 311/312 hazard categories follow the classification in Section 2. |
| California Proposition 65 | No ingredient is listed as known to the State of California to cause cancer or reproductive toxicity. |
| State right-to-know lists | No ingredient is listed. |
| US FDA | The active substance is also the active ingredient of an approved drug product (epoetin alfa); the material described here is not that approved product, has not been manufactured under cGMP for human use and is sold for laboratory research use only. |
| US DEA controlled substances | No ingredient is scheduled under the Controlled Substances Act at the revision date. |
| Anti-doping (information only) | Erythropoietin (rhEPO): WADA Prohibited List, class S2. |
| International | The classification in Section 2 applies equally under EU CLP (Regulation (EC) 1272/2008) and other UN GHS implementations; peptides of this kind are generally not registered under REACH (research and development use). |
16Other information
| Revision | Revision 1.0, October 3, 2026 — first issue. Prepared by PrymaLab Analytical, PrymaLab LLC. |
|---|---|
| Classification method | Substance classification adopted from the supplier safety data sheets listed below, with the PrymaLab policy adjustments stated in Section 11. Policy: Cayman Chemical is the primary reference for research peptides and novel small molecules and Sigma-Aldrich/Merck for commodity chemicals; a more conservative manufacturer or ECHA classification is adopted where internally consistent; SARMs, GLP-1 receptor agonists, GnRH analogues and gonadotropins carry reproductive-toxicity classifications by expert judgement. |
| Sources consulted | Amgen; Janssen / Johnson & Johnson; Sigma-Aldrich E5546; R&D Systems / Bio-Techne 287-TC. |
| Abbreviations | ATE acute toxicity estimate · CAS Chemical Abstracts Service · GHS Globally Harmonized System · HCS Hazard Communication Standard · IARC International Agency for Research on Cancer · LD50/LC50 median lethal dose/concentration · NTP National Toxicology Program · OEL occupational exposure limit · PEL permissible exposure limit · STOT specific target organ toxicity · TLV threshold limit value · WADA World Anti-Doping Agency. |
