ALENDRONATE SODIUM

PRODUCT IDENTIFICATION

CAS NO. 121268-17-5

ALENDRONATE SODIUM

EINECS NO.  
FORMULA C4H12NO7P2Na·3H2O
MOL WT. 325.12

H.S. CODE

 

TOXICITY

 

SYNONYMS Sodium alendronate hydrate;
(4-Amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate; 4-Amino-1-hydroxy-1-phosphonobutyl phosphonic acid, monosodium, trihydrate; Monosodium (4-amino-1-hydroxybutylidene)bisphosphonate trihydrate; Aminohydroxybutylidene biphosphonate monosodium salt; Alendronic acid monosodium salt trihydrate;

CLASSIFICATION

BONE DENSITY REGULATORS /

PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL STATE white crystalline powder
MELTING POINT  
BOILING POINT

 

SPECIFIC GRAVITY

 

SOLUBILITY IN WATER 10 mg/ml
pH 4.2 - 5.5
VAPOR DENSITY

 

AUTOIGNITION

 

NFPA RATINGS

 

REFRACTIVE INDEX

 

FLASH POINT

 

STABILITY

Stable under ordinary conditions.

APPLICATIONS

Alendronate sodium is a bisphosphonate which binds to the hydroxyapatite in bone and act as a inhibitor of the resorption of bone for the treatment of osteitis deformans, postmenopausal osteoporosis, and hypercalcemia related to malignancy. It is a white crystalline powder; soluble in water, slightly soluble in alcohol, and insoluble in chloroform, acetone and acetic acid. It is a farnesyl diphosphate synthase inhibitor and tyrosine (protein) phosphatase inhibitor. Chemically, it is described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate. It is administered orally.

Biphosphonate, a salt, ester, or anion of a dimer of phosphonic acid (diphosphonic acid), inhibits bone resorption as a sodium salt and complexed with technetium Tc 99m for bone imaging. The monophosphonates are not active. Biphosphonates are used in disorders affecting the skeleton such as osteoporosis, metastatic disease, and Paget's disease. While bisphosphonates are analogues of endogenous pyrophosphate structurally, they are characterized by a P-C-P bond, the linking oxygen is replaced with a carbon, which is resistant to enzymatic and chemical hydrolysis. General structure is

Bisphosphonate

Side chains are responsible for chemical-physicla properties, mechanism of resorption, and pharmacokinetics. It is known that biphosphonates bind strongly to hydroxyapatite crystals at the sites of increased bone turnover preferentially and inhibit the formation, aggregation, and dissolution of the crystals.They also may inhibit osteoclast function directly, promotion of osteoclast apoptosis, and interference with osteoblast-mediated osteoclast activation.
Bisphosphonate products include: (see below)

  • Etidronic acid (CAS #: 2809-21-4)
  • Clodronic acid (CAS #: 10596-23-3)
  • Tiludronic acid (CAS #: 89987-06-4)
  • Medronic acid (CAS #: 1984-15-2)
  • Pamidronic acid (CAS #: 40391-99-9)
  • Neridronic acid (CAS #: 79778-41-9)
  • Olpadronic acid (CAS #: 63132-39-8)
  • Alendronic acid (CAS #: 66376-36-1)
  • Ibandronic acid (CAS #: 114084-78-5)
  • Risedronic acid (CAS #: 105462-24-6)
  • Zoledronic Acid (CAS #: 118072-93-8)

Medication members for the treatment of postmenopausal osteoporosis in women by building healthy bone and restoring some of the bone loss as a result of osteoporosis include vitamin D and calcium supplements, bisphosphonate drugs, certain selective estrogen receptor modulators, estrogen replacements and parathyroid hormones. Examples are below:

Bone Density Regulators

CAS RN

Alendronate sodium 121268-17-5
Alendronic acid 66376-36-1
Calcifediol 63283-36-3
Calcitonin 47931-85-1
Calcitriol 32222-06-3

Cholecalciferol

67-97-0
Clodronic acid 10596-23-3
Dihydrotachysterol 67-96-9
Disodium cycloheptylaminomethylenediphosphonate 138330-18-4
Ergocalciferol 50-14-6
Etidronate Disodium 7414-83-7
Etidronic acid 2809-21-4
Gallium nitrate 135886-70-3
Hydroxycholecalciferols

 

Ibandronate sodium hydrate 138926-19-9

Ibandronic acid

114084-78-5

Olpadronic acid

63132-39-8
Oxidronic acid 15468-10-7
Pamidronate disodium 109552-15-0
Pamidronic acid disodium salt 57248-88-1
Pamidronic acid 40391-99-9
Potassium phosphate dibasic 7758-11-4
Procalcitonin 56645-65-9

Raloxifene

84449-90-1
Risedronate sodium 115436-72-1

Risedronic acid

105462-24-6
Secalciferol 55721-11-4

Tamoxifen

10540-29-1

Teriparatide

52232-67-4

Tiludronic acid

89987-06-4
Toremifene citrate 89778-27-8

Toremifene

89778-26-7

Vitamin D

1406-16-2
Vitamin D2 sulfate 1784-46-9

Zoledronic acid

118072-93-8
24,25-Dihydroxyvitamin D 3 40013-87-4

25-Hydroxyvitamin D 2

21343-40-8
SALES SPECIFICATION

APPEARANCE

white crystalline powder

ASSAY

98.0 - 102.0%

WATER

15.0 - 19.0%

HEAVY METALS

10ppm max

CLARITY OF SOLUTION

clear and colorless

TRANSPORTATION
PACKING

 

HAZARD CLASS  
UN NO.  
OTHER INFORMATION
Hazard Symbols: XI, Risk Phrases: 36/37/38, Safety Phrases: 26-36

BISPHOSPHONATE PRODUCTS

Biphosphonate
(Sosium salt)

CAS #

Side Chains
(R1, R2)

STRUCTURE

Alendronic acid
(Alendronate)
66376-36-1

R1= -OH
R2= -C
3H6NH2

Alendronic acid

Clodronic acid
(Clodronate)
10596-23-3

R1= -Cl
R2= -Cl

Clodronic acid

Etidronic acid
(Etidronate)
2809-21-4

R1= -OH
R2= -CH
3

Etidronic acid

Ibandronic acid
(Ibandronate)
114084-78-5

R1= -OH
R2= -C
2H4N(CH3)C5H11

Ibandronic acid

Medronic acid
(Medronate)
1984-15-2

R1= -H
R2= -H

Medronic acid

Neridronic acid
(Neridronate)
79778-41-9

R1= -OH
R2= -C
5H10NH2

Neridronic acid

Olpadronic acid
(Olpadronate)
63132-39-8

R1= -OH
R2= -C
2H4N(CH3)2

Olpadronic acid

Pamidronic acid
(Pamidronate)
40391-99-9

R1= -OH
R2= -C
2H4NH2

Pamidronic acid

Risedronic acid
(Risedronate)
105462-24-6

R1= -OH
R2= Risedronic acid R2

Risedronic acid

Tiludronic acid
(Tiludronate)
89987-06-4

R1= -H
R2= -S-CH
4Cl

Tiludronic acid

Zoledronic Acid
(Zoldronate)
118072-93-8

R1= -OH
R2= Zoledronic Acid R2

Zoledronic Acid

PRICE INFORMATION
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