Description

Technetium Tc 99M n-(Methylamino)Methylene Diphosphonate is a diagnostic radiopharmaceutical agent used in nuclear medicine imaging. This compound is critical for its ability to target and visualize skeletal structures, providing high-contrast images of bone metabolism. It is primarily needed by radiopharmacies, nuclear medicine departments in hospitals, and clinical research organizations for conducting bone scintigraphy scans. The agent is prepared from a sterile, non-pyrogenic, lyophilized kit and is intended for intravenous administration after reconstitution with sterile Sodium Pertechnetate Tc 99m Injection.

Application

• Bone Scintigraphy (Bone Scan): Primary application for detecting skeletal abnormalities such as metastases, fractures, infections (osteomyelitis), and evaluating prosthetic joints.
• Oncology: Staging and monitoring of bone involvement in cancers like breast, prostate, and lung cancer.
• Orthopedics: Assessment of unexplained bone pain, trauma, sports injuries, and evaluating the viability of bone grafts.
• Rheumatology: Diagnosis and evaluation of metabolic bone diseases, Paget's disease, and complex regional pain syndrome.
• Cardiac Amyloidosis Imaging: Used in some protocols to detect transthyretin-related cardiac amyloidosis due to its affinity for amyloid deposits.
• Research & Development: Used in preclinical and clinical studies for developing new diagnostic protocols and evaluating therapeutic responses.

Basic Information

Product Name	Technetium Tc 99M n-(Methylamino)Methylene Diphosphonate
CAS No.	66225-82-9
Molecular Formula	C3H11NO7P2 • 99mTc
Molecular Weight	Contact for details
Synonyms	Technetium Tc-99m MDP; Tc-99m MDP; MDP Kit; Methylene Diphosphonate, Technetium Tc 99m Labeled; Oxidronic Acid Tc-99m; (99mTc)MDP; NSC-103991; Bone Scan Agent; Medronate Tc-99m
EINECS	Contact for details

Quality Control

Our radiopharmaceutical kits and intermediates are manufactured under strict cGMP conditions in dedicated facilities. Each batch undergoes comprehensive testing for sterility, bacterial endotoxins, pH, radiochemical purity (RCP), and aluminum content to ensure compliance with major pharmacopoeial standards (USP, Ph. Eur.). A Certificate of Analysis (COA) detailing all release specifications is provided with every shipment.

Storage

Preserve the lyophilized kit in the original sealed vial within a tightly closed container. Store at 2°C to 8°C (refrigerated, do not freeze). Protect from all light exposure. The final prepared Technetium Tc 99m MDP injection should be used within the validated time frame post-reconstitution, typically within 6-8 hours, and stored at room temperature during this period.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or cake
pH (after reconstitution)	5.0 - 7.0
Radiochemical Purity (RCP)	≥ 95.0% (by ITLC/HPLC)
Sterility Test	Sterile
Bacterial Endotoxins	< 175 EU/Vial
Aluminum Content	< 10 µg/mL
Identification (HPLC/Radio-TLC)	Conforms to standard
Assay (SnCl2•2H2O content)	0.10 - 0.30 mg/vial

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.