| Product Name | Teriparatide Acetate |
| CAS No. |
52232-67-4 |
| Sequence | H-Ser-Val-Ser-Glu-Ile-Gln-Leu-Met-His-Asn-Leu-Gly-Lys-His-Leu-Asn-Ser-Met-Glu-Arg-Val-Glu-Trp-Leu-Arg-Lys-Lys-Leu-Gln-Asp-Val-His-Asn-Phe-OH |
| Purity | 99% |
| Molecular Formula | C184H282N50O60S |
| Molar Mass | Soluble to 0.40 mg/ml in water |
| Appearance | White powder |
| Application | Healthcare |
| Impurity | ≤0.5% |
| Package | Aluminum Bag or Drum |
| Packing Size | 1G/Bottle, 10G/Bottle,50G/Bottle or at customers reqirement. |
| Storage | Store in a closed container in a cool and dry place, below 5ºC. |
| Retest Date | 2 years |
| Storage Temperature | 2-8ºC |
Products Description
What is Teriparatide acetate?
Name: Teriparatide acetate
Synonyms: PARATHYROID HORMONE HUMAN: FRAGMENT1-34
CAS Number: 52232-67-4
Molecular formula: C172H278N52O47S2
Molecular weight: 3890.49792
EINECS number: 640-978-1
Form: powder
Storage conditions: −20°C
Teriparatide Acate is a synthetic of human parathyroid hormone (PTH). It is derived from the 34 amino acids of the full-length PTH and is used in the treatment of osteoporosis. Teriparatide Acetate is commonly marketed under the brand name Forteo.


Product COA
Certificate Of Analysis
|
Product Name |
Teriparatide Acetate |
|
||
|
Chemical Formula |
C172H278N52O47S2 |
Molecular Weight |
3890.49792 | |
|
CAS |
52232-67-4 |
Batch Quantity |
400kg |
|
|
Batch No. |
MLP-PPH-20231114 |
Manufacture Date |
2025.11.14 |
|
|
Report Date |
2025.11.17 |
Retest Date |
2027.11.13 |
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|
Testing Items |
Specifications | Test Results | |
|
BP2010 /EP6 |
Appearance |
crystalline powder |
Conforms |
|
Melting point |
About 205°C |
206.4°C~206.7°C |
|
|
Identification |
Meet the requirements |
Conforms |
|
|
Appearance of solution |
Clear, not more intense than Y7 |
Conforms |
|
|
PH |
2.4~3.0 |
2.60 |
|
|
Loss on drying |
≤0.5% |
0.04% |
|
|
Sulphated ash |
≤0.1% |
0.01% |
|
|
Heavy metals |
≤20 ppm |
<20 ppm |
|
|
Related substances |
≤0.25% |
Conforms |
|
|
Assay |
99.0%~101.0% |
99.8% |
|
|
USP32 |
Identification |
Meet the requirements |
Conforms |
|
Loss on drying |
≤0.5% |
0.04% |
|
|
Residue on ignition |
≤0.1% |
0.01% |
|
|
Heavy metals |
≤0.003% |
<0.003% |
|
|
Residue solvent - Ethanol |
≤0.5% |
<0.04% |
|
|
Chloride |
16.9%~17.6% |
17.1% |
|
|
Assay |
98.0%~102.0% |
100.0% |
|
|
Conclusion: The product complies with BP2010/USP32/EP6 standard |
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Main Functions & Pharmacological Effects
Teriparatide Acetate is primarily used to increase bone formation and improve bone density in individuals with osteoporosis. It works by stimulating osteoblast activity, which are the cells responsible for bone formation. By promoting new bone growth, Teriparatide Acetate helps to reduce the risk of fractures and strengthens the skeletal structure. Additionally, it increases calcium absorption from the intestines and enhances renal reabsorption of calcium, contributing to overall bone health.
Promotes bone formationIt preferentially stimulates osteoblast activity to boost new bone growth, increase bone mineral density and improve bone structure.
Enhances calcium absorptionIt improves intestinal calcium absorption and regulates calcium and phosphorus metabolism in the body.
Reduces fracture riskBy strengthening bone tissue, it significantly lowers the incidence of vertebral and non-vertebral fractures.
Applications of Teriparatide Acetate
Teriparatide Acetate is administered through daily subcutaneous injections, typically for a duration of up to 24 months. It is prescribed to postmenopausal women and men with a high risk of fractures or those who have failed or are intolerant to other available osteoporosis treatments. Teriparatide Acetate is also used in the treatment of glucocorticoid-induced osteoporosis, a condition caused by long-term use of glucocorticoid medications. Additionally, it may be prescribed to individuals with primary or hypogonadal osteoporosis. Regular monitoring of bone density and calcium levels is essential during treatment with Teriparatide Acetate to ensure its efficacy and safety.
OsteoporosisIt is mainly used for the treatment of severe osteoporosis in postmenopausal women and men at high risk of fractures, especially for patients who fail to respond to other anti-osteoporosis drugs.
Glucocorticoid-induced osteoporosisIndicated for adults with osteoporosis caused by long-term glucocorticoid therapy who have a high fracture risk.
Hypoparathyroidism (off-label use in some regions)It may be used to manage hypoparathyroidism to maintain normal blood calcium levels.
Dosage of Teriparatide Acetate
Standard daily regimen: 20 mcg injected subcutaneously once daily, preferably in the morning. Rotate injection sites (thigh, abdomen, or upper arm) to avoid skin irritation.
Alternative regimens: Clinical studies have explored twice-weekly administration (e.g., 80 mcg per dose) as a well-tolerated option with favorable bone mineral density outcomes, though this is not universally approved.
Treatment duration: The maximum recommended continuous treatment period is 24 months due to potential long-term safety considerations.
Important Precautions
Contraindications
Do not use if you have a history of osteosarcoma or other bone cancers, have received radiation therapy to the skeleton, or have severe kidney impairment (creatinine clearance <30 mL/min).
Avoid during pregnancy and breastfeeding, as safety in these populations has not been established.
Safety Warnings
Hypercalcemia: Monitor blood calcium levels regularly, especially in patients with pre-existing hypercalcemia or kidney disease. Symptoms include excessive thirst, frequent urination, and fatigue.
Orthostatic hypotension: May cause dizziness or fainting, particularly after the first few doses. Avoid driving or operating machinery until you know how the medication affects you.
Osteosarcoma risk: Although rare, long-term use may theoretically increase osteosarcoma risk based on animal studies. Avoid in patients with Paget's disease of bone or unexplained elevated alkaline phosphatase levels.
Administration Guidelines
Store unopened pens in the refrigerator (2°C to 8°C/36°F to 46°F). Once opened, pens can be stored at room temperature (up to 25°C/77°F) for up to 28 days.
Do not freeze or shake the pre-filled injection pens.
If a dose is missed, take it as soon as you remember on the same day. Do not double doses to make up for a missed one.
Precautions for Using Teriparatide Acetate
Treatment duration limitThe maximum continuous use is 2 years. Long-term administration may raise the risk of osteosarcoma, so extended use is not allowed.
Contraindicated populationsDo not use it in patients with a history of bone tumors, metastatic bone disease, Paget's disease of bone, unexplained elevated alkaline phosphatase, or prior radiation therapy to the skeleton. It is also contraindicated in pregnant and breastfeeding women.
Calcium and blood calcium monitoringIt may cause transient hypercalcemia. Monitor serum calcium regularly, especially at the early stage of treatment. Patients with pre-existing hypercalcemia or hyperparathyroidism cannot take this drug.
Orthostatic hypotension riskDizziness and orthostatic hypotension may occur after injection. Avoid driving, operating machinery or standing up rapidly right after administration.
Special groupsSafety and efficacy in children and adolescents have not been confirmed, so it is not recommended for this group.
Administration rulesIt is for subcutaneous injection only. Do not inject intravenously or intramuscularly. Follow proper refrigeration and storage requirements for the drug.
Combination useBe cautious when combined with drugs that increase blood calcium. Supplemental calcium and vitamin D should be used appropriately as advised, while avoiding excessive intake.
How Teriparatide Acetate Works
Teriparatide acetate is a recombinant fragment of human parathyroid hormone (PTH 1-34). It acts uniquely on bone metabolism when administered as a daily intermittent injection.
Stimulates bone formationIntermittent dosing primarily activates osteoblasts (bone-forming cells), accelerating the growth of new bone tissue. This increases bone mass and improves bone microarchitecture.
Moderately regulates bone resorptionUnlike continuous high PTH levels which break down bone, its intermittent use only slightly affects osteoclasts (bone-resorbing cells). The net effect is a significant gain in bone.
Regulates calcium and phosphorus balanceIt boosts intestinal absorption of calcium and reabsorption of calcium in the kidneys, while lowering blood phosphorus levels. This maintains normal serum calcium and supports bone mineralization.
Reduces fracture riskBy raising bone mineral density and strengthening bone structure, it effectively decreases the risk of vertebral and non-vertebral fractures.
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Packaging & Shipping
Delivery Time:Around 3-5 workdays after your payment.
Package:1kg/aluminium foil bag;25Kgs in fiber-drums with two-plastic bags inside
Net Weight:25kgs/Drum/Gross Weight:28kgs/Drum
Drum Size & Volume:I.D.42cm × H52cm,0.08 m³/Drum
Storage:Stored in dry and cool place,keep away from strong light and heat.
Shelf Life:Two years when properly stored.
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Package |
1kg/bag ,25kg/bag;25kg/drum; customize as customer's equirements. |
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Transit |
Fedex, TNT,DHL,EMS,and so on. |
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Shipping port |
Shanghai/Tianjin/Dalian/Beijing/Xi'an |
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Lead Time |
1-2 working days upon received the payment |
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For mass orders, it will be delivered by air or sea. |
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