Disusun oleh :
Golongan C-II / Kelompok A
1. Moh. Arikus Wibowo (17/411937/FA/11366)
2. Muhammad Sulhan Hadi (17/411939/FA/11368)
3. Ni Putu Desy Anggraeni (17/411941/FA/11370)
Kelas/Golongan : C/II A
Dosen Pembimbing : Dr. Eng. Khadijah, M.Si., Apt.
Jumlah Bahan
No. Pemerian Bahan Baku Tiap Satuan Tiap Batch
Kode (tiap 10 mL) (untuk 100 mL)
1. Teofilin (C7H8N4O2)
Sinonim: 1,3-dimetilxantin
Struktur senyawa: 2 𝑔𝑟𝑎𝑚 2 gram
=
10
= 0,2 gram/10
mL
= 200 mg/10
mL
(PubChem, 2020)
2
4. Natrium Klorida
Sinonim : garam dapur, natrii chloridum qs qs
Struktur senyawa:
Dokumen hanya untuk kalangan sendiri , segala bentuk peniruan dan penggandaan harus seijin
laboratorium.
3
PERHITUNGAN TONISITAS
4
PRODUKSI
Lab. Teknologi Farmasi Fakultas Farmasi UGM Jumlah Halaman : No.Halaman :
+ NaCl qs
5
Diukur volume campuran, jika volume belum 100 mL, ad
100 mL aqua bebas CO2
7
ANALISIS DATA
1. Pemilihan Formula dan Penentuan Konsentrasi Komponen Formula
Formula
R/ Teofilin 2
Etilendiamin 0,3
Aqua p.i. ad 100 mL
NaCl q.s.
Pada percobaan ini bertujuan untuk mengetahui cara pembuatan sediaan injeksi aminofilin
2,4%, cara sterilisasi dan kontrol kualitas sediaan tersebut. Sediaan injeksi adalah sediaan yang
steril, yaitu sediaan harus bebas dari mikroorganisme, yang mana sediaan steril ini disuntikkan
melalui kulit atau selaput lendir. Aminofilin adalah golongan xantin yang memiliki gugus metil
dan rumus kimia 2,6-Dioksipurin. Dalam Daftar Obat Esensial Nasional (DOEN) tahun 2013,
aminofilin adalah obat yang digunakan untuk terapi saat terjadi eksaserbasi asma.
Injeksi aminofilin adalah larutan steril aminofilin dalam air untuk injeksi atau laurtan steril
teofilin dalam air untuk injeksi yang dibuat dengan penambahan etilendiamin. Tiap ml
mengandung aminofilin setara dengan tidak kurang dari 93,0% dan tidak lebih dari 107,0%
teofilin anhidrat, C7H8N4O2, dari jumlah yang tertera pada etiket. Injeksi aminofilin boleh
mengandung etilendiamin berlebih tetapi tidak boleh ditambah zat lain untuk pengaturan pH
(Depkes RI, 2014).
Teofilin dalam formula berfungsi sebagai zat aktif yang dapat mengatasi bronkospasme.
Etilendiamin dalam formula berfungsi untuk membantu kelarutan teofilin agar mudah larut
dalam air sehingga diharapkan sediaan injeksi yang terbentuk adalah larutan sejati yang mana
semua bahan yang digunakan dapat larut sempurna dalam air (pembawa). Teofilin memiliki
kelarutan yang rendah dalam air sehingga memerlukan etilendiamin agar teofilin dapat larut
dalam air, karena teofilin dan etilendiamin akan membentuk garam yang mudah larut dalam
air. Aqua p.i. merupakan pembawa sediaan injeksi yang umum digunakan. NaCl dalam
formula berfungsi untuk menjaga tonisitas sediaan agar tetap isotonis dengan cairan biologis
tubuh manusia sehingga sediaan injeksi yang dihasilkan tidak akan mengganggu
keseimbangan sel-sel tubuh maupun memberikan efek yang merugikan bagi tubuh pasien.
Jumlah etilendiamin yang digunakan dalam praktikum ini dikurangi, karena jika dilihat
dari reaksi yang terjadi pada pembentukan aminofilin, jumlah etilendiamin yang digunakan
berlebihan sehingga dapat memberikan sisa atau residu etilendiamin yang tidak bereaksi
menjadi aminofilin. Hal ini dapat mempengaruhi tonisitas dari sediaan injeksi sehingga sediaan
injeksi menjadi hipertonis. Untuk menghindari hal tersebut maka etilendiamin dikurangi
jumlahnya menjadi 0,3 gram untuk 100 mL larutan injeksi. Dengan jumlah yang baru ini,
sediaan injeksi menjadi hipotonis dan akan ditambahkan Natrium klorida agar menjadi
isotonis. Jumlah NaCl yang harus ditambahkan dalam sediaan akan dihitung dengan
perhitungan tonisitas.
2. +
2. +
Berat molekul:
- Teofilin :180,16 g/mol
- Etilendiamin : 60,1 g/mol
Kadar zat dalam g/L
2 𝑔𝑟𝑎𝑚 20 𝑔𝑟𝑎𝑚
- Teofilin : 100 𝑚𝐿 = 1000 𝑚𝐿 = 20 g/L
0,3 𝑔𝑟𝑎𝑚 3 𝑔𝑟𝑎𝑚
- Etilendiamin : = 1000 𝑚𝐿 = 3 g/L
100 𝑚𝐿
Faktor disosiasi
Dikatakan suatu larutan isotonis bila terpenuhi:
𝐹𝑎 𝐹𝑏
×𝑎+ × 𝑏 + … = 0,28
𝑀𝑎 𝑀𝑏
Perhitungan:
1,5 1,5
× 20 + 60,1 × 3 = 0,242 → 0,242 < 0,28 sehingga larutan sediaan injeksi tersebut bersifat
180,16
Hipotonis, maka perlu penambahan bahan pengisotonis yaitu NaCl agar larutan menjadi
isotonis. Larutan yang bersifat hipotonis tidak boleh digunakan untuk sediaan steril karena
dapat menyebabkan sel mengalami lisis akibat pergerakan air ke dalam sel secara terus
menerus.
Daftar Pustaka
Anonim, 2016, Autoklaf – Cara Aman dan Efektif Menggunakan Autoklaf, tersedia di
http://batavialab.com, diakses pada tanggal 15 April 2020 pada pukul 20.56 WIB.
Depkes RI, 2014, Farmakope Indonesia, Edisi V, Depkes RI, Jakarta.
Kementerian Kesehatan Republik Indonesia, 2013, Keputusan Menteri Kesehatan Republik
Indonesia Nomor 312/MENKES.SK/IX/2013 tentang Daftar Obat Esensial Nasional
(DOEN) 2013, Kementerian Kesehatan Republik Indonesia, Jakarta.
Salehuddin, M.F.H., 2017, STB3182 Standar Oprating Procedure for Handling Autoclave
Machine, tersedia di https://youtu.be/aG-dS5WzFOM, diakses pada tanggal 15 April 2020
pukul 20.53 WIB.
LAMPIRAN
Gambar Cara Penggunaan Autoklaf
(Batavialab.com)
Next Page
(Salehuddin, 2017)
LAMPIRAN
Gambar Glassware
Ampul
Erlenmeyer
Beaker glass
Corong
Gelas ukur
Neraca Analitik
SECTION 1: Identification
1.1. Identification
Product form : Mixtures
Product name : Ethylenediamine, 70% Technical Grade
Product code : LC14140
1.2. Recommended use and restrictions on use
Use of the substance/mixture : For laboratory and manufacturing use only.
Recommended use : Laboratory chemicals
Restrictions on use : Not for food, drug or household use
1.3. Supplier
LabChem Inc
Jackson's Pointe Commerce Park Building 1000, 1010 Jackson's Pointe Court
Zelienople, PA 16063 - USA
T 412-826-5230 - F 724-473-0647
info@labchem.com - www.labchem.com
P272 - Contaminated work clothing should not be allowed out of the workplace.
P280 - Wear protective gloves, protective clothing, eye protection, face protection.
P284 - Wear respiratory protection.
P301+P330+P331 - IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P303+P361+P353 - IF ON SKIN (or hair): Remove/Take off immediately all contaminated
clothing. Rinse skin with water/shower.
P305+P351+P338 - If in eyes: Rinse cautiously with water for several minutes. Remove contact
lenses, if present and easy to do. Continue rinsing
P310 - Immediately call a poison center or doctor/physician.
P363 - Wash contaminated clothing before reuse.
P403+P235 - Store in a well-ventilated place. Keep cool.
P405 - Store locked up.
P501 - Dispose of contents/container to comply with local, state and federal regulations
If inhaled: Remove person to fresh air and keep comfortable for breathing
2.3. Other hazards which do not result in classification
Other hazards not contributing to the : None under normal conditions.
classification
2.4. Unknown acute toxicity (GHS US)
Not applicable
Ethylenediamine (107-15-3)
OSHA OSHA PEL (TWA) (ppm) 10 ppm
IDLH US IDLH (ppm) 1000 ppm
NIOSH NIOSH REL (TWA) (mg/m³) 25 mg/m³
NIOSH NIOSH REL (TWA) (ppm) 10 ppm
Water (7732-18-5)
Not applicable
Hand protection:
Wear protective gloves.
Eye protection:
Chemical goggles or face shield
Respiratory protection:
Gas mask
Other information:
Do not eat, drink or smoke during use.
Potential Adverse human health effects and : Based on available data, the classification criteria are not met. Harmful if swallowed. Harmful in
symptoms contact with skin.
Symptoms/effects after inhalation : May cause allergy or asthma symptoms or breathing difficulties if inhaled. May cause an
allergic skin reaction.
Symptoms/effects after skin contact : Repeated exposure to this material can result in absorption through skin causing significant
health hazard. Harmful in contact with skin.
Symptoms/effects after eye contact : Causes serious eye damage.
Symptoms/effects after ingestion : Swallowing a small quantity of this material will result in serious health hazard.
Water (7732-18-5)
Persistence and degradability Not established.
Water (7732-18-5)
Bioaccumulative potential Not established.
UN-No.(DOT) : UN1604
Proper Shipping Name (DOT) : Ethylenediamine
solution
Transport hazard class(es) (DOT) : 8 - Class 8 - Corrosive material 49 CFR 173.136
Packing group (DOT) : II - Medium Danger
Ethylenediamine (107-15-3)
RQ (Reportable quantity, section 304 of EPA's 5000 lb
List of Lists)
SARA Section 302 Threshold Planning 10000 lb
Quantity (TPQ)
SARA Section 311/312 Hazard Classes Physical hazard - Flammable (gases, aerosols, liquids, or solids)
Health hazard - Acute toxicity (any route of exposure)
Health hazard - Skin corrosion or Irritation
Health hazard - Serious eye damage or eye irritation
Health hazard - Respiratory or skin sensitization
EU-Regulations
No additional information available
National regulations
Ethylenediamine (107-15-3)
Listed on the Canadian IDL (Ingredient Disclosure List)
Hazard Rating
Health : 3 Serious Hazard - Major injury likely unless prompt action is taken and medical treatment is
given
Flammability : 3 Serious Hazard - Materials capable of ignition under almost all normal temperature
conditions. Includes flammable liquids with flash points below 73 F and boiling points above
100 F. as well as liquids with flash points between 73 F and 100 F. (Classes IB & IC)
Physical : 0 Minimal Hazard - Materials that are normally stable, even under fire conditions, and will NOT
react with water, polymerize, decompose, condense, or self-react. Non-Explosives.
Personal protection : H
H - Splash goggles, Gloves, Synthetic apron, Vapor respirator
SDS US LabChem
Information in this SDS is from available published sources and is believed to be accurate. No warranty, express or implied, is made and LabChem Inc assumes no liability resulting from the use of this
SDS. The user must determine suitability of this information for his application.
Date Issued: November 3, 2004 Version: 4.0 Revision Issued: March 2, 2017
Section I – Product and Company Identification
INTREPID POTASH – MOAB, LLC
707 17th St. Suite 4200
Denver, CO 80202
Office 303-296-3006
Fax 303-298-7502
Web http://www.intrepidpotash.com/Contact.aspx
Common Name: Fine Salt, Medium Salt, Road Use: Animal Feed and
Formula: NaCl Synonym: Salt
Salt, Coarse Salt Industrial
Page 1 of 5
Section V – Fire Fighting Measures
Flash Point: None Auto-ignition Temperature: Not Applicable Lower Explosive Limit: Not Applicable
Upper Explosive Limit: Not Applicable
Extinguishing Media: As required for surrounding fire. Salt is non-flammable and does not support combustion.
Full structural firefighting (bunker) gear is the minimum acceptable attire. The need for proximity, entry,
flashover and/or special chemical protective clothing (see Section 8) needs to be determined for each
Special Firefighting
incident by a competent firefighting safety professional. Water used for fire suppression and cooling
Procedures and Equipment:
may become exposed to soluble fertilizer. Discharge to sewer system(s) or environment may be
restricted, requiring containment and proper disposal of water.
Storage: Store in a dry location. Avoid contact with aluminum or carbon steel to minimize corrosion.
Protective Clothing: Gloves, long sleeve shirts and long pants. Launder work clothing regularly.
Minimum NIOSH approved N95 filter type dust respirators until engineering controls are
Respiratory Protection:
implemented.
Other Protective Clothing or Equipment: Optional
Page 2 of 5
Section X – Stability and Reactivity
Stability: Stable.
Hazardous Polymerization: Will not occur
Conditions to Avoid: None
Strong oxidizing agents, strong acids. In the presence of moisture it may be
Materials to Avoid (Incompatibilities):
mildly corrosive to metals.
When heated to decomposition (above 1413 degree Celsius) may emit toxic
Hazardous Decomposition Products: fumes of Na2O and Cl2. May evolve chlorine gas when in contact with strong
acids.
Page 3 of 5
Section XIII – Disposal Considerations
This material, if discarded as produced, is not a RCRA “listed” or “characteristic” hazardous waste.
Product Disposal: Contamination may subject it to hazardous waste regulations. Properly characterize all waste materials.
Consult State and local regulations regarding the proper disposal of this material.
General Comments: Because of its solubility Salt should not be disposed of in a location where run-off will escape.
SARA Hazard This product has been reviewed according to the EPA Hazard Categories promulgated under Section 311 and 312
Category: of the Superfund Amendment and Reauthorization Act of 1986 (SARA Title III) and is considered, under applicable
definitions, to meet the following categories:
Fire: No Pressure Generating: No Reactivity: No Acute: No Chronic: No
SARA Title III This product contains the following substances subject to the reporting requirements of Title III(EPCRA) of the
Information: Superfund Amendments and Reauthorization Act of 1986 and 40 CFR Part 372:
Percent by CERCLA RQ
Chemical CAS No.
Weight (lbs.)
Ingredient Disclosure List: This product does not contain ingredient(s) on this list
Environmental Protection: All intentional ingredients are listed on the DSL (Domestic Substance List).
Page 4 of 5
Section XVI – Other Information
NFPA Hazard Rating: Health: 1 Flammability: 0 Instability: 0 Special Hazard: N/A
Section(s) changed since last revision: SDS is designed to comply with U.S. DOL: OSHA and MSHA HazCom standards in effect on the
revision date.
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief as of the revision date noted below. This information
is not a warranty or quality specification. The user of the product is solely responsible for determining the suitability of use in each particular situation. This
information relates only to the specific material designated and may not be valid for the material used in combination with any other materials or in any process.
The user of the product assumes all risks and responsibilities in connection with the use of the product, and Intrepid will not be responsible for any damages relating
to the use of the product.
Page 5 of 5
SAFETY DATA SHEET Page: 1 of 5
according to Regulation (EC) No. 1907/2006 as amended by (EC) No. 2015/830 and US OSHA HCS 2015
1.2 Relevant identified uses of the substance or mixture and uses advised against:
Relevant identified uses: For research use only, not for human or veterinary use.
Multi-region format
SAFETY DATA SHEET Page: 2 of 5
Multi-region format
SAFETY DATA SHEET Page: 3 of 5
Multi-region format
SAFETY DATA SHEET Page: 4 of 5
Multi-region format
SAFETY DATA SHEET Page: 5 of 5
Regulatory Information This SDS was prepared in accordance with 29 CFR 1910.1200 and Regulation (EC)
Statement: No.1272/2008.
Multi-region format
SDS AquaPro
Conforms to HazCom 2012/United States
The following recommendations for exposure controls and personal protection are intended for the manufacture, formulation and packaging of this product.
For applications and/or use, consult the product label. The label directions supersede the text of this Safety Data Sheet for application and/or use.
Page 1 of 9
Inhalation: Move person to fresh air. If person is not breathing, call an emergency responder or
ambulance, then give artificial respiration; if by mouth to mouth use rescuer protection (pocket
mask etc). Call a poison control center or doctor for treatment advice.
Skin contact: Take off contaminated clothing. Rinse skin immediately with plenty of water for 15-20 minutes.
Call a poison control center or doctor for treatment advice.
Eye contact: Hold eyes open and rinse slowly and gently with water for 15-20 minutes. Remove contact
lenses, if present, after the first 5 minutes, then continue rinsing eyes. Call a poison control
center or doctor for treatment advice.
Notes to physician: No specific antidote. Treatment of exposure should be directed at the control of symptoms
and the clinical condition of the patient. Have the Safety Data Sheet, and if available, the
product container or label with you when calling a poison control center or doctor, or going for
treatment.
Unsuitable extinguishing
media: no data available
Hazardous combustion
products: During a fire, smoke may contain the original material in addition to combustion products of
varying composition which may be toxic and/or irritating.
Page 2 of 9
Special protective
equipment for firefighters: Wear positive-pressure self-contained breathing apparatus (SCBA) and protective fire fighting
clothing (includes fire fighting helmet, coat, trousers, boots, and gloves). Avoid contact with
this material during fire fighting operations. If contact is likely, change to full chemical resistant
fire fighting clothing with self-contained breathing apparatus. If this is not available, wear full
chemical resistant clothing with self-contained breathing apparatus and fight fire from a
remote location. For protective equipment in post-fire or non-fire clean-up situations, refer to
the relevant sections.
Environmental precautions: Prevent from entering into soil, ditches, sewers, waterways and/or groundwater. See Section
12, Ecological Information.
Conditions for safe storage: Minimize sources of ignition, such as static build-up, heat, spark or flame. Keep container
closed. Do not store in: Carbon steel. Galvanized containers. Steel. Flammable mixtures may
exist within the vapor space of containers at room temperature. Store in a dry place. Store in
original container. Do not store near food, foodstuffs, drugs or potable water supplies.
RECOMMENDATIONS IN THIS SECTION ARE FOR MANUFACTURING, COMMERCIAL BLENDING AND PACKAGING
WORKERS. APPLICATORS AND HANDLERS SHOULD SEE THE PRODUCT LABEL FOR PROPER PERSONAL
PROTECTIVE EQUIPMENT AND CLOTHING.
Exposure controls
Engineering controls: Good general ventilation should be sufficient for most conditions. Local exhaust ventilation
may be necessary for some operations.
Respiratory protection: Atmospheric levels should be maintained below the exposure guideline. When respiratory
protection is required for certain operations, use an approved air-purifying respirator.
The following should be effective types of air-purifying respirators: Organic vapor cartridge
with a particulate pre-filter.
NOTE: The physical data presented above are typical values and should not be construed as a specification.
Possibility of hazardous
reactions: Polymerization will not occur.
Conditions to avoid: Active ingredient decomposes at elevated temperatures. Avoid static discharge.
Incompatible materials: Heat produced by the reaction with water will cause vaporization. Flammable hydrogen may
be generated from contact with metals such as:
Hazardous decomposition
products: Decomposition products depend upon temperature, air supply and the presence of other
materials.
Acute toxicity
Acute oral toxicity Very low toxicity if swallowed. Harmful effects not anticipated from swallowing small amounts.
LD50, Rat, > 5,000 mg/kg
Acute dermal toxicity Prolonged skin contact is unlikely to result in absorption of harmful amounts.
LD50, Rabbit,> 5,000 mg/kg
Acute inhalation toxicity Brief exposure (minutes) is not likely to cause adverse effects.
LC50, Rat, 4 Hour, Aerosol, > 6.37 mg/L
Sensitization Did not cause allergic skin reactions when tested in guinea pigs.
Carcinogenicity For similar material(s): Glyphosate. Did not cause cancer in laboratory animals.
Teratogenicity For the active ingredient(s): Available data are inadequate for evaluation of potential to cause
birth defects.
Reproductive toxicity For the active ingredient(s): Available data are inadequate to determine effects on
reproduction.
Mutagenicity For the active ingredient(s): In vitro genetic toxicity studies were negative in some cases and
positive in other cases.
For similar material(s): Glyphosate. In vitro genetic toxicity studies were negative. Animal genetic
toxicity studies were negative.
Acute toxicity to fish Material is practically non-toxic to aquatic organisms on an acute basis
(LC50/EC50/EL50/LL50 > 100 mg/L in the most sensitive species tested).
Acute toxicity to
aquatic invertebrates EC50, Daphnia magna (Water flea), 48 Hour, 918 mg/L,
OECD Test Guideline 202 or Equivalent
Acute toxicity to
algae/aquatic plants EC50, Pseudokirchneriella subcapitata (green algae), 72 Hour, Biomass, 10- 127 mg/L,
OECD Test Guideline 201 or Equivalent
Toxicity to
Above Ground Organisms Material is practically non-toxic to birds on an acute basis (LD50 > 2000 mg/kg).
oral LD50, Colinus virginianus (Bobwhite quail), > 2,000 mg/kg
contact LD50, Apis mellifera (bees), > 100µg/bee
oral LD50, Apis mellifera (bees), > 100µg/bee
Page 6 of 9
Bloaccumulative potential
Bioaccumulation: For similar active ingredient(s). Bioconcentration potential is low (BCF < 100 or Log Pow< 3).
Mobility in soil For similar active ingredient(s): Expected to be relatively immobile in soil (Koc > 5000).
Classification for
SEA transport (IMO-IMDG): Not regulated for transport
This information is not intended to convey all specific regulatory or operational requirements/information relating to this product.
Transportation classifications may vary by container volume and may be influenced by regional or country variations in regulations.
Additional transportation system information can be obtained through an authorized sales or customer service representative. It is the
responsibility of the transporting organization to follow all applicable laws, regulations and rules relating to the transportation of the
material.
Page 7 of 9
California Proposition 65
(Safe Drinking Water and
Toxic Enforcement Act
of 1986) This product contains no listed substances known to the State of California to cause cancer,
birth defects or other reproductive harm, at levels which would require a warning under the
statute.
Components CASRN
lsopropylamine 75-31-0
United States TSCA Inventory This product contains chemical substance(s) exempt from U.S. EPA TSCA Inventory
requirements. It is regulated as a pesticide subject to Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) requirements.
CAUTION
Harmful if inhaled
Legend
ACGIH USA. ACGIH Threshold Limit Values (TLV
OSHA Z-1 USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
STEL Short-term exposure limit
TWA 8-hour, time-weighted average
History
Date of issue: 08/11/2015
Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above -named supplier, nor any of its subsidiaries,
assumes any liability whatsoever for the accuracy or completeness of the information contained herein. Final determination of suitability of any
material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards
are described herein, we cannot guarantee that these are the only hazards that exist.
Page 9 of 9